Genesis Reusable Rigid Container System

K142529 · Carefusion 2200, Inc. · KCT · Jan 8, 2015 · General Hospital

Device Facts

• Record ID: K142529
• Device Name: Genesis Reusable Rigid Container System
• Applicant: Carefusion 2200, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jan 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days. Containers are suitable for dynamic air re-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use. Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container. Data cards are used to recording a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

Device Story

Genesis Reusable Rigid Sterilization Container System; rigid, stackable containers for housing medical instruments during sterilization and storage. Input: medical devices placed in baskets/racks within container. Operation: container lid, bottom, filter, and tamper-evident arrows facilitate sterilant ingress/egress while maintaining microbial barrier. Output: sterilized medical devices ready for clinical use. Used in healthcare facilities; operated by sterile processing staff. Healthcare providers use the system to ensure instrument sterility; benefits include organized, protected, and sterile storage of surgical instrumentation until needed.

Clinical Evidence

No clinical tests were conducted. Evidence is based on non-clinical bench testing, including sterilization efficacy (12-log reduction, SAL 10^-6) and dry time validation per ST77:2013 standards.

Technological Characteristics

Materials: Anodized aluminum (5000/1100 series), 300/400 series stainless steel, silicone elastomer gaskets, SMS polypropylene filters. Design: Rigid, stackable containers with baskets, dividers, and racks. Sterilization: Dynamic air removal steam, immediate use pre-vacuum steam, 100% ethylene oxide. Volume-to-vent ratio: 24.0 to 182.3 in³/in².

Indications for Use

Indicated for healthcare providers to enclose medical devices for sterilization and storage (up to 180 days). Suitable for dynamic air removal (pre-vacuum) steam, immediate use pre-vacuum steam, and 100% ethylene oxide sterilization. Compatible with intrinsically stable metals, composites, and polymers.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Genesis™ Reusable Sterilization Container System (K140850)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human face in profile, with three overlapping profiles to represent the department's focus on health, human services, and the well-being of the nation. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2015

CareFusion 2200 Inc. Ms. Jane Weber Regulatory Affairs Manager 75 N. Fairway Drive Vernon Hills, IL 60061

Re: K142529

Trade/Device Name: Genesis™ Reusable Rigid Sterilization Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap, Containers, Trays, Cassettes and Other Accessories Regulatory Class: II Product Code: KCT Dated: December 5, 2014 Received: December 8, 2014

Dear Ms. Weber:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Weber

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

of Surveillance and Biometrics/Division of Postmarket Surveillance.

Sincerely yours,

Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Indications for Use

510(k) Number (if known) K142529

#### Device Name

Genesis Reusable Rigid Sterilization Container System

#### Indications for Use (Describe)

The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.

Containers are suitable for dynamic air re-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.

Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.

Data cards are used to recording a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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# Sterilization Parameters for the Genesis™ Reusable Rigid Container System by Modality

| Sterilization<br>Method | Cycle Parameters | Total<br>System<br>Weight | Applicable<br>Containers/Accessories |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dynamic Air<br>Removal<br>(Pre-Vacuum)<br>Steam | Exposure Temperature: 270°F<br>(132°C)<br>Pre-Conditioning Pulses: 3<br>Exposure Time: 4 Minutes<br>Dry Time Cycle: 30 minutes<br>Minimum Cool Time: 60 minutes<br>(may vary according to load contents)<br>Stack Height: Maximum 3 | 25 lbs. | Solid Bottom Containers;<br>Perforated Bottom Containers;<br>Stacking Baskets<br>Non-Stacking Baskets<br>Lumen Devices (2.68 mm x 450 mm) - Qty 16<br>Lumen Devices (1.37 mm x 242 mm) - Qty 10<br>Devices or Device Configurations<br>entailing conjoined surfaces which<br>meet, touch or unite;<br>Silicone Support Bars<br>Silicone Mats<br>Laparoscopic Racks<br>Optional Protective Plate<br>Materials: Metals, Polymers,<br>Composites |
| Dynamic Air<br>Removal<br>(Pre-Vacuum)<br>Steam<br>Immediate Use | Exposure Temperature: 270°F<br>(132°C)<br>Pre-Conditioning Pulses: 3<br>Exposure Time: 4 Minutes<br>Stack Height: Maximum 3<br>Note: Devices must be used<br>immediately and cannot be<br>stored for later use. | 25 lbs. | Solid Bottom Containers;<br>Perforated Bottom Containers;<br>Stacking Baskets<br>Non-Stacking Baskets<br>Lumen Devices (2.68 mm x 450 mm) - Qty 16<br>Lumen Devices (1.37 mm x 242 mm) - Qty 10<br>Devices or Device Configurations<br>entailing conjoined surfaces which<br>meet, touch or unite;<br>Silicone Support Bars<br>Silicone Mats<br>Laparoscopic Racks<br>Optional Protective Plate<br>*Materials: Metals, Polymers,<br>Composites |
| 100% Ethylene<br>Oxide | EO Sterilant Concentration:<br>100% EO, 725 mg/L<br>Pre-Conditioning Time: 30<br>minutes<br>Temperature: 130°F (55°C)<br>Exposure Time: 60 minutes<br>Relative Humidity: 50-80%<br>Aeration: 8 hours @ 109.4°F<br>(43°C)<br>No stacking | 15 lbs. | Perforated Bottom Containers<br>except CD2-10BDL and DINCD2-<br>8B);<br>Non Stacking Baskets<br>Lumen Devices (3.0 mm x 400 mm) - Qty 5<br>Device or Device Configurations<br>entailing conjoined surfaces which<br>meet, touch or unite;<br>Silicone Support Bars;<br>Laparoscopic Racks;<br>Materials: Stainless Steel,<br>Aluminum, Silicone, Radel |

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Examples of instrument types that are conjoined include: scissors, forceps, clamps (including double action), hand held and self retaining retractors, needle holders, osteotomes/chisels, rongeurs, kerrison rongeurs, specula.

Note: Air tight occluded challenges are devices entailing surfaces that are completely obstructed. These types of devices have not been validated for use in the Genesis Reusable Sterilization Container System.

*Materials: Intrinsically stable metals. Composites, thermosetting polymers with constant use temperatures above 135°C.

Examples of intrinsically stable metals include stainless steel, titanium (CP and aluminum. Examples of thermoplastic polymers are PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile/Butadiene/ Styrene) and POM (Polyoxymethylene). Examples of thermosetting polymers are Phenolic and Silicone. Examples of composites include carbon fiber reinforced epoxy (CFRE).

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| Type of Container | Contents/Configuration | Pre-Vacuum Steam | 100 % Ethylene Oxide |
|---------------------------------|------------------------------------------|--------------------------------------------|-----------------------------------------------|
| Solid Bottom | Non Stacking Baskets | Yes | No |
| Container | Stacking Baskets | Yes | No |
| | Lumen: 1.37 mm (ID) x 242<br>mm(L) | Yes, maximum 10 | No |
| | Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No |
| | Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | No |
| | Occluded/Mated Challenge | Yes | No |
| | Silicone Support Bar | Yes | No |
| | Silicone Mat | Yes | No |
| | Laparoscopic Rack | Yes | No |
| | Optional Protective Plate | Yes | No |
| | Filter | NST Series | No |
| | Data Card | MD1-1 | No |
| | Tamper-Evident Arrow | White AS Series | No |
| | Stack Height | 3 | No |
| | Materials | Materials: Metals,<br>Polymers, Composites | No |
| | Maximum Total Container System<br>Weight | 25 lbs. | No |
| Perforated Bottom | Non Stacking Baskets | Yes | Yes |
| Container | Stacking Baskets | Yes | No |
| | Lumen: 1.37 mm (ID) x 242<br>mm(L) | Yes, maximum 10 | No |
| | Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No |
| | Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | Yes, maximum 5 |
| | Occluded/Mated challenge | Yes | Yes |
| | Silicone Support Bars | Yes | Yes |
| | Silicone Mat | Yes | No |
| Note: The CD2- | Laparoscopic Rack | Yes | Yes |
| 10BDL and | Optional Protective Plate | Yes | No |
| DINCD2-8B | Filter | NST series | NST series |
| container models | Data Cards | MD1-1 | MD1-1 |
| are not validated | Tamper Evident Arrow | White AS Series | Yellow AG Series |
| for use in 100% | Stack Height | 3 max | No stacking |
| Ethylene Oxide<br>sterilization | Materials | Materials: Metals,<br>Polymers, Composites | Radel, Stainless Steel,<br>Aluminum, Silicone |
| | Maximum Total Weight | 25 lbs. | 15 lbs. |
| STERRAD | Non Stacking Baskets | Yes | Yes |
| Compatible | Stacking Baskets | Yes | No |
| Containers | Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 2 | No |
| | Lumen: 3.0mm (ID) x 400mm (L) | Yes, maximum 2 | Yes, maximum 5 |
| | Occluded/Mated Challenge | Yes | Yes |
| | Silicone Support Bars | Yes | Yes |
| | Silicone Mat | Yes | No |
| | Laparoscopic Rack | Yes | Yes |
| | Optional Protective Plate | Yes | No |
| | Filter | NST Series | NST Series |
| | Data Cards | MD1-1 | MD1-1 |
| | Tamper-Evident Arrow | White AS Series | Yellow AG Series |
| | Stack Height | 3 Maximum | No stacking |
| | Materials | Materials: Metals,<br>Polymers, Composites | Radel, Stainless Steel,<br>Aluminum, Silicone |
| | Maximum Total Container System<br>Weight | 25 lbs. | 15 lbs. |

# Accessories and Device Challenges by Sterilization Modality and Container Style

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#### Solid Bottom Containers

| Catalog Code | Description | Container Dimension (in) | Container<br>Weight<br>(lb.) |
|--------------|---------------------------|--------------------------|------------------------------|
| CD0-4C | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.4 |
| CD1-4C | Half Length Container | 11.8 x 12.4 x 4.5 | 4.8 |
| CD1-5C | Half Length Container | 11.8 x 12.4 x 5.3 | 5.0 |
| CD1-6C | Half Length Container | 11.8 x 12.4 x 6.1 | 5.2 |
| CD2-4C | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.4 |
| CD2-5C | Mid Length Container | 19.2 x 12.4 x 5.3 | 6.7 |
| CD2-6C | Mid Length Container | 19.2 x 12.4 x 6.1 | 6.9 |
| CD2-8C | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.3 |
| CD3-4C | Full Length Container | 23.1 x 12.4 x 4.5 | 7.8 |
| CD3-5C | Full Length Container | 23.1 x 12.4 x 5.3 | 7.9 |
| CD3-6C | Full Length Container | 23.1 x 12.4 x 6.1 | 8.2 |
| CD3-7C | Full Length Container | 23.1 x 12.4 x 7.0 | 8.5 |
| CD7-5C | Extra Long Container | 25.2 x 12.4 x 5.9 | 8.5 |
| CD7-6C | Extra Long Container | 25.2 x 12.4 x 6.7 | 8.8 |
| CD7-9C | Extra Long Container | 25.2 x 12.4 x 8.4 | 9.7 |
| CD4-3C | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5C | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.2 |
| CD5-3C | Large Narrow Container | 28.1 x 11.2 x 5.0 | 8.4 |
| CD5-61C | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.1 |
| CD0-3C | Mini Container | 10.2 x 7.2 x 3.2 | 2.5 |
| CD6-6C | Retractor Container | 26.5 x 17.0 x 6.9 | 12.4 |
| CD1-7CDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.3 |
| CD1-8CDL | Half Length Container | 11.9 x 12.5 x 8.3 | 5.5 |
| CD2-7CDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.1 |
| CD2-10CDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD3-8CDL | Full Length Container | 23.1 x 12.5 x 7.8 | 8.8 |
| CD3-9CDL | Full Length Container | 23.1 x 12.5 x 8.8 | 8.6 |
| DINCD3-5C | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 7.9 |
| DINCD3-6C | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 8.2 |
| DINCD3-7C | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 8.5 |
| DINCD2-5C | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 6.7 |
| DINCD2-6C | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 6.9 |
| DINCD2-8C | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.3 |
| DINCD1-5C | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.0 |
| DINCD1-6C | Half Length Container | 11.6 x 11.4 x 6.1 | 5.2 |

#### Perforated Bottom Containers

| Catalog Code | Description | Container Dimension (in) | Container<br>Weight<br>(lb.) |
|--------------|--------------------------|--------------------------|------------------------------|
| CD0-4B | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4B | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5B | Half Length Container | 11.8 x 12.4 x 5.3 | 5.5 |
| CD1-6B | Half Length Container | 11.8 x 12.4 x 6.1 | 5.7 |
| CD2-4B | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5B | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.1 |
| CD2-6B | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.4 |
| CD2-8B | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.8 |
| CD3-4B | Full Length Container | 23.1 x 12.4 x 4.5 | 8.5 |
| CD3-5B | Full Length Container | 23.1 x 12.4 x 5.3 | 8.8 |
| CD3-6B | Full Length Container | 23.1 x 12.4 x 6.1 | 9.0 |
| CD3-7B | Full Length Container | 23.1 x 12.4 x 7.0 | 9.4 |
| CD7-5B | Extra Long Container | 25.2 x 12.4 x 5.9 | 9.0 |
| CD7-6B | Extra Long Container | 25.2 x 12.4 x 6.7 | 9.4 |

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| Catalog Code | Description | Container Dimension (in) | Container<br>Weight<br>(lb.) |
|--------------|---------------------------|--------------------------|------------------------------|
| CD7-9B | Extra Long Container | 25.2 x 12.4 x 8.4 | 10.0 |
| CD4-3B | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.5 |
| CD4-5B | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.0 |
| CD5-3B | Large Narrow Container | 28.1 x 11.2 x 5.0 | 9.1 |
| CD5-61B | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.5 |
| CD0-3B | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
| CD6-6B | Retractor Container | 26.5 x 17.0 x 6.9 | 13.9 |
| CD1-7BDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.8 |
| CD1-8BDL | Half Length Container | 11.9 x 12.5 x 8.3 | 6.0 |
| CD2-10BDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD2-7BDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.5 |
| CD3-8BDL | Full Length Container | 23.1 x 12.5 x 7.8 | 9.6 |
| CD3-9BDL | Full Length Container | 23.1 x 12.5 x 8.8 | 9.9 |
| DINCD3-5B | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 8.8 |
| DINCD3-6B | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 9.0 |
| DINCD3-7B | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 9.4 |
| DINCD2-5B | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 7.1 |
| DINCD2-6B | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 7.4 |
| DINCD2-8B | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.8 |
| DINCD1-5B | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.5 |
| DINCD1-6B | Half Length DIN Container | 11.6 x 11.4 x 6.1 | 5.7 |

#### STERRAD Style Containers

| Catalog Code | Description | Container Dimension (In) | Container<br>Weight<br>(lb.) |
|--------------|--------------------------------|--------------------------|------------------------------|
| CD0-4ST | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4ST | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5ST | Half Length Container | 11.8 x 12.4 x 5.3 | 5.4 |
| CD1-6ST | Half Length Container | 11.8 x 12.4 x 6.1 | 5.6 |
| CD2-4ST | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5ST | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.0 |
| CD2-6ST | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.2 |
| CD2-8ST | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.7 |
| CD3-4ST | Full Length Container | 23.1 x 12.4 x 4.5 | 8.4 |
| CD3-5ST | Full Length Containers | 23.1 x 12.4 x 5.3 | 8.6 |
| CD3-6ST | Full Length Containers | 23.1 x 12.4 x 6.1 | 8.9 |
| CD3-7ST | Full Length Containers | 23.1 x 12.4 x 7.0 | 9.3 |
| CD4-3ST | Small Narrow Shallow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5ST | Small Narrow Container | 20.8 x 7.3 x 5.2 | 4.8 |
| CD5-3ST | Large Narrow Shallow Container | 28.1 x 11.2 x 5.0 | 8.9 |
| CD5-61ST | Large Narrow Shallow Container | 28.1 x 11.2 x 6.4 | 9.4 |
| CD0-3ST | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |

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eFusion

# K142529 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

| SUBMITTER INFORMATION | |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | CareFusion 2200 Inc |
| Address | 75 N. Fairway Dr.<br>Vernon Hills, IL 60061 |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment<br>Registration Number | 1423507 |
| Name of contact person | Jane Weber, Regulatory Affairs Manager |
| Date prepared | 05-JAN-2015 |
| DEVICE INFORMATION | |
| Trade or proprietary<br>name | Genesis™ Reusable Rigid Sterilization Container System |
| Common or usual name | Sterilization Container |
| Classification name | Sterilization Wrap, Containers, Trays, Cassettes and Other Accessories |
| Classification panel | 80 |
| Regulation | Class II per 21CFR 880.6850, Product code KCT |
| Product Code(s) | KCT |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | Genesis™ Reusable Sterilization Container System<br>K140850 |
| Reason for 510(k)<br>submission | Expand indications for use regarding the quantity and types of lumen devices<br>to be sterilized using the pre-vacuum steam sterilization modality in the<br>Genesis Container System. |
| Device description | The Genesis Reusable Rigid Container System is an assortment of rigid,<br>reusable, stackable containers that are used to sterilize other medical devices<br>and maintain sterility of these devices until used. The container system is<br>comprised of a lid, bottom, filter, tamper evident arrows, and data cards.<br>The container system houses baskets of varying depths and organizing<br>accessory devices that are used to organize and to secure surgical<br>instrumentation and/or other medical devices. |

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# sion

### UMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| Characteristic | Predicate Device - K140850 | New/Modified Device |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | A sterilization container system is a device<br>intended to be used to enclose another<br>medical device that is to be sterilized by a<br>health care provider. It is intended to allow<br>sterilization of the enclosed medical device<br>and also to maintain sterility of the enclosed<br>medical device until used. | Same |
| Container | Anodized aluminum 5000 and 1100<br>series; stainless steel 300 series | Same |
| Gasket | Closed cell silicone foam | Same |
| Filter | SMS polypropylene for all sterilization<br>modalities | Same |
| Baskets | 304 Stainless Steel, electropolished | Same |
| Dividers, brackets | Aluminum 5000 series | Same |
| Clips, posts, pins | Stainless steel 300 and 400 series | Same |
| Silicone bars, mats | Silicone Elastomer | Same |
| Material Compatibility<br>(materials to be sterilized<br>within container) | Intrinsically stable metals, composites,<br>thermoplastics and thermosetting polymers<br>with constant use temperatures above 135°C. | Same |
| Volume to Vent Ratio | $24.0 \text{ to } 182.3 \frac{in^3}{in^2}$ | Same |
| Sterilization parameters<br>for Pre-Vacuum steam for<br>Lumen devices | Lumens: 2.68 mm (ID) x 450 mm (L) – Qty 2 | Lumens: 2.68 mm (ID) x 450 mm (L) –<br>Qty 16<br>Lumens 1.37 mm (ID) x 242 mm (L) –<br>Qty 10 |

### PERFORMANCE DATA

### SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

#### Performance Test Summary-New Device

| Characteristic | Standard/Test/FDA Guidance | Results Summary |
|--------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Sterilization Efficacy: Pre-vacuum Steam | ST 77 2013 Containment Devices for Reusable Medical Device Sterilization | Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using biological (BI) overkill method |
| Dry Time for Dynamic Air Removal (Pre-vacuum steam modality) | ST 77 2013 Containment Devices for Reusable Medical Device Sterilization | Testing demonstrated validated method of drying by absence of visible moisture |

{11}------------------------------------------------

CareFusion

#### EQUIVALENCE AND/OR OF CLINICAL INFORMATION

N/A - No clinical tests were conducted for this submission.

#### CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The Genesis Reusable Rigid Container System has been validated to meet the established performance criteria. The results of the verification studies demonstrate that the sterilization containers perform as intended and based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device, Class II (21 CFR 880.6850), Product code KCT.

### INDICATIONS FOR USE

The Genesis Reusable Rigid Sterilization Container System is a device intended to enclose another medical device that is to be sterilized by a health care provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed medical device until used for a maximum of 180 days.

Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use prevacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.

Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.

Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

{12}------------------------------------------------

# areFusion

## Sterilization Parameters for the Genesis Reusable Rigid Container System by Modality

| Sterilization<br>Method | Cycle Parameters | Total<br>System<br>Weight | Applicable<br>Containers/Accessories |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dynamic Air<br>Removal<br>(Pre-Vacuum)<br>Steam | Exposure Temperature: 270°F<br>(132°C)<br><br>Pre-Conditioning Pulses: 3<br><br>Exposure Time: 4 Minutes<br><br>Dry Time Cycle: 30 minutes<br><br>Minimum Cool Time: 60<br>minutes<br>(may vary according to load<br>contents)<br><br>Stack Height: Maximum 3 | 25 lbs. | Solid Bottom Containers;<br>Perforated Bottom Containers;<br>Stacking Baskets<br>Non-Stacking Baskets<br>Lumen Devices (2.68 mm x 450<br>mm) - Qty 16<br>Lumen Devices (1.37 mm x 242<br>mm) - Qty 10<br>Devices or Device Configurations<br>entailing conjoined surfaces which<br>meet, touch or unite;<br>Silicone Support Bars<br>Silicone Mats<br>Laparoscopic Racks<br>Optional Protective Plate<br>Materials: Metals, Polymers,<br>Composites |
| Dynamic Air<br>Removal<br>(Pre-Vacuum)<br>Steam<br>Immediate Use | Exposure Temperature: 270°F<br>(132°C)<br><br>Pre-Conditioning Pulses: 3<br><br>Exposure Time: 4 Minutes<br><br>Stack Height: Maximum 3<br><br>Note: Devices must be used<br>immediately and cannot be<br>stored for later use. | 25 lbs. | Solid Bottom Containers;<br>Perforated Bottom Containers;<br>Stacking Baskets<br>Non-Stacking Baskets<br>Lumen Devices (2.68 mm x 450<br>mm) - Qty 16<br>Lumen Devices (1.37 mm x 242<br>mm) - Qty 10<br>Devices or Device Configurations<br>entailing conjoined surfaces which<br>meet, touch or unite;<br>Silicone Support Bars<br>Silicone Mats<br>Laparoscopic Racks<br>Optional Protective Plate<br>*Materials: Metals, Polymers,<br>Composites |
| 100% Ethylene<br>Oxide | EO Sterilant Concentration:<br>100% EO, 725 mg/L<br><br>Pre-Conditioning Time: 30<br>minutes<br><br>Temperature: 130°F (55°C)<br><br>Exposure Time: 60 minutes<br><br>Relative Humidity: S0-80%<br><br>Aeration: 8 hours @ 109.4°F<br>(43°C)<br><br>No stacking | 15 lbs. | Perforated Bottom Containers<br>except CD2-10BDL and DINCD2-<br>8B);<br>Non Stacking Baskets<br>Lumen Devices (3.0 mm x 400<br>mm) — Qty 5<br>Device or Device Configurations<br>entailing conjoined surfaces which<br>meet, touch or unite;<br>Silicone Support Bars;<br>Laparoscopic Racks;<br>Materials: Stainless Steel,<br>Aluminum, Silicone, Radel |

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a yellow accent on the top right.

Examples of instrument types that are conjoined include: scissors, forceps, clamps (including double action), hand held and self retaining retractors, needle holders, osteotomes/chisels, rongeurs, kerrison rongeurs, specula.

Note: Air tight occluded challenges are devices entailing surfaces that are completely obstructed. These types of devices have not been validated for use in the Genesis Reusable Sterilization Container System.

*Materials: Intrinsically stable metals. Composites, and thermosetting polymers with constant use temperatures above 135°C.

Examples of intrinsically stable metals include stainless steel, titanium (CP and aluminum. Examples of thermoplastic polymers are PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile/Butadiene/ Styrene) and POM (Polyoxymethylene). Examples of thermosetting polymers are Phenolic and Silicone. Examples of composites include carbon fiber reinforced epoxy (CFRE).

{14}------------------------------------------------

# Fusion

| Accessories and Device Challenges by Sterilization Modality and Container Style | | |
|---------------------------------------------------------------------------------|--|--|
|---------------------------------------------------------------------------------|--|--|

| Type of Container | Contents/Configuration | Pre-Vacuum Steam | 100 % Ethylene Oxide |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------|-----------------------------------------------|
| Solid Bottom<br>Container | Non Stacking Baskets | Yes | No |
| | Stacking Baskets | Yes | No |
| | Lumen: 1.37 mm (ID) x 242 mm (L) | Yes, maximum 10 | No |
| | Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No |
| | Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | No |
| | Occluded/Mated Challenge | Yes | No |
| | Silicone Support Bar | Yes | No |
| | Silicone Mat | Yes | No |
| | Laparoscopic Rack | Yes | No |
| | Optional Protective Plate | Yes | No |
| | Filter | NST Series | No |
| | Data Card | MD1-1 | No |
| | Tamper-Evident Arrow | White AS Series | No |
| | Stack Height | 3 | No |
| | Materials | Materials: Metals,<br>Polymers, Composites | No |
| | Maximum Total Container System<br>Weight | 25 lbs. | No |
| Perforated Bottom<br>Container | Non Stacking Baskets | Yes | Yes |
| | Stacking Baskets | Yes | No |
| | Lumen: 1.37 mm (ID) x 242 mm(L) | Yes, maximum 10 | No |
| | Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 16 | No |
| | Lumen: 3 mm (ID) x 400 mm (L) | Yes, maximum 2 | Yes, maximum 5 |
| | Occluded/Mated Challenge | Yes | Yes |
| | Silicone Support Bars | Yes | Yes |
| | Silicone Mat | Yes | No |
| | Laparoscopic Rack | Yes | Yes |
| | Optional Protective Plate | Yes | No |
| | Filter | NST series | NST series |
| | Data Cards | MD1-1 | MD1-1 |
| | Tamper Evident Arrow | White AS Series | Yellow AG Series |
| | Stack Height | 3 max | No stacking |
| | Materials | Materials: Metals,<br>Polymers, Composites | Radel, Stainless Steel,<br>Aluminum, Silicone |
| | Maximum Total Weight | 25 lbs. | 15 lbs. |
| STERRAD<br>Compatible<br>Containers | Non Stacking Baskets | Yes | Yes |
| | Stacking Baskets | Yes | No |
| | Lumen: 2.68mm (ID) x 450mm (L) | Yes, maximum 2 | No |
| | Lumen: 3.0mm (ID) x 400mm (L) | Yes, maximum 2 | Yes, maximum 5 |
| | Occluded/Mated Challenge | Yes | Yes |
| | Silicone Support Bars | Yes | Yes |
| | Silicone Mat | Yes | No |
| | Laparoscopic Rack | Yes | Yes |
| | Optional Protective Plate | Yes | No |
| | Filter | NST Series | NST Series |
| | Data Cards | MD1-1 | MD1-1 |
| | Tamper-Evident Arrow | White AS Series | Yellow AG Series |
| | Stack Height | 3 Maximum | No stacking |
| | Materials | Materials: Metals,<br>Polymers, Composites | Radel, Stainless Steel,<br>Aluminum, Silicone |
| | Maximum Total Container System<br>Weight | 25 lbs. | 15 lbs. |
| Note: The CD2-10BDL and DINCD2-8B container models are not validated for use in 100% Ethylene Oxide sterilization | | | |

{15}------------------------------------------------

Image /page/15/Picture/1 description: The image contains the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a small orange accent in the upper left corner.

### Solid Bottom Containers

| Catalog Code | Description | Container Dimension (in) | Container<br>Weight<br>(lb.) |
|--------------|---------------------------|--------------------------|------------------------------|
| CD0-4C | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.4 |
| CD1-4C | Half Length Container | 11.8 x 12.4 x 4.5 | 4.8 |
| CD1-5C | Half Length Container | 11.8 x 12.4 x 5.3 | 5.0 |
| CD1-6C | Half Length Container | 11.8 x 12.4 x 6.1 | 5.2 |
| CD2-4C | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.4 |
| CD2-5C | Mid Length Container | 19.2 x 12.4 x 5.3 | 6.7 |
| CD2-6C | Mid Length Container | 19.2 x 12.4 x 6.1 | 6.9 |
| CD2-8C | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.3 |
| CD3-4C | Full Length Container | 23.1 x 12.4 x 4.5 | 7.8 |
| CD3-5C | Full Length Container | 23.1 x 12.4 x 5.3 | 7.9 |
| CD3-6C | Full Length Container | 23.1 x 12.4 x 6.1 | 8.2 |
| CD3-7C | Full Length Container | 23.1 x 12.4 x 7.0 | 8.5 |
| CD7-5C | Extra Long Container | 25.2 x 12.4 x 5.9 | 8.5 |
| CD7-6C | Extra Long Container | 25.2 x 12.4 x 6.7 | 8.8 |
| CD7-9C | Extra Long Container | 25.2 x 12.4 x 8.4 | 9.7 |
| CD4-3C | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5C | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.2 |
| CD5-3C | Large Narrow Container | 28.1 x 11.2 x 5.0 | 8.4 |
| CD5-61C | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.1 |
| CD0-3C | Mini Container | 10.2 x 7.2 x 3.2 | 2.5 |
| CD6-6C | Retractor Container | 26.5 x 17.0 x 6.9 | 12.4 |
| CD1-7CDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.3 |
| CD1-8CDL | Half Length Container | 11.9 x 12.5 x 8.3 | 5.5 |
| CD2-7CDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.1 |
| CD2-10CDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD3-8CDL | Full Length Container | 23.1 x 12.5 x 7.8 | 8.8 |
| CD3-9CDL | Full Length Container | 23.1 x 12.5 x 8.8 | 8.6 |
| DINCD3-5C | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 7.9 |
| DINCD3-6C | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 8.2 |
| DINCD3-7C | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 8.5 |
| DINCD2-5C | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 6.7 |
| DINCD2-6C | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 6.9 |
| DINCD2-8C | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.3 |
| DINCD1-5C | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.0 |
| DINCD1-6C | Half Length Container | 11.6 x 11.4 x 6.1 | 5.2 |

#### Perforated Bottom Containers

| Catalog Code | Description | Container Dimension (in) | Container<br>Weight<br>(lb.) |
|--------------|--------------------------|--------------------------|------------------------------|
| CD0-4B | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4B | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5B | Half Length Container | 11.8 x 12.4 x 5.3 | 5.5 |
| CD1-6B | Half Length Container | 11.8 x 12.4 x 6.1 | 5.7 |
| CD2-4B | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5B | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.1 |
| CD2-6B | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.4 |
| CD2-8B | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.8 |
| CD3-4B | Full Length Container | 23.1 x 12.4 x 4.5 | 8.5 |
| CD3-5B | Full Length Container | 23.1 x 12.4 x 5.3 | 8.8 |
| CD3-6B | Full Length Container | 23.1 x 12.4 x 6.1 | 9.0 |
| CD3-7B | Full Length Container | 23.1 x 12.4 x 7.0 | 9.4 |

{16}------------------------------------------------

# sion

| Catalog Code | Description | Container Dimension (in) | Container<br>Weight<br>(lb.) |
|--------------|---------------------------|--------------------------|------------------------------|
| CD7-5B | Extra Long Container | 25.2 x 12.4 x 5.9 | 9.0 |
| CD7-6B | Extra Long Container | 25.2 x 12.4 x 6.7 | 9.4 |
| CD7-9B | Extra Long Container | 25.2 x 12.4 x 8.4 | 10.0 |
| CD4-3B | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.5 |
| CD4-5B | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.0 |
| CD5-3B | Large Narrow Container | 28.1 x 11.2 x 5.0 | 9.1 |
| CD5-61B | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.5 |
| CD0-3B | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
| CD6-6B | Retractor Container | 26.5 x 17.0 x 6.9 | 13.9 |
| CD1-7BDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.8 |
| CD1-8BDL | Half Length Container | 11.9 x 12.5 x 8.3 | 6.0 |
| CD2-10BDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD2-7BDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.5 |
| CD3-8BDL | Full Length Container | 23.1 x 12.5 x 7.8 | 9.6 |
| CD3-9BDL | Full Length Container | 23.1 x 12.5 x 8.8 | 9.9 |
| DINCD3-5B | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 8.8 |
| DINCD3-6B | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 9.0 |
| DINCD3-7B | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 9.4 |
| DINCD2-5B | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 7.1 |
| DINCD2-6B | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 7.4 |
| DINCD2-8B | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.8 |
| DINCD1-5B | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.5 |
| DINCD1-6B | Half Length DIN Container | 11.6 x 11.4 x 6.1 | 5.7 |

#### STERRAD Style Containers

| Catalog Code | Description | Container Dimension (In) | Container<br>Weight<br>(lb.) |
|--------------|--------------------------------|--------------------------|------------------------------|
| CD0-4ST | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4ST | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5ST | Half Length Container | 11.8 x 12.4 x 5.3 | 5.4 |
| CD1-6ST | Half Length Container | 11.8 x 12.4 x 6.1 | 5.6 |
| CD2-4ST | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5ST | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.0 |
| CD2-6ST | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.2 |
| CD2-8ST | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.7 |
| CD3-4ST | Full Length Container | 23.1 x 12.4 x 4.5 | 8.4 |
| CD3-5ST | Full Length Containers | 23.1 x 12.4 x 5.3 | 8.6 |
| CD3-6ST | Full Length Containers | 23.1 x 12.4 x 6.1 | 8.9 |
| CD3-7ST | Full Length Containers | 23.1 x 12.4 x 7.…