Who is the manufacturer of Steriking® LT-Blueline Pouches with Tyvek®?

Wipak OY filed the 510(k) submission for Steriking® LT-Blueline Pouches with Tyvek® (K231999).

What is the FDA product code for Steriking® LT-Blueline Pouches with Tyvek®?

FRG. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Steriking® LT-Blueline Pouches with Tyvek®?

510(k) clearance (submission type: Special).

What are the predicate devices for Steriking® LT-Blueline Pouches with Tyvek®?

Steriking® LT-Blueline Pouches with Tyvek® (K221377).

Who can help prepare an FDA 510(k) submission like Steriking® LT-Blueline Pouches with Tyvek®?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Steriking® LT-Blueline Pouches with Tyvek®

K231999 · Wipak OY · FRG · Sep 7, 2023 · General Hospital

Device Facts

Record ID	K231999
Device Name	Steriking® LT-Blueline Pouches with Tyvek®
Applicant	Wipak OY
Product Code	FRG · General Hospital
Decision Date	Sep 7, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® Sterilizer Systems. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 years post sterilization. The products are for single use only. The Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERRAD® Sterilization Cycles: NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard

Device Story

Steriking® LT-Blueline Pouches with Tyvek® are single-use sterilization packaging for medical devices; constructed from Tyvek® and BOPET/PE plastic film; heat-sealed on three sides with an integrated adhesive strip on the fourth side for self-sealing by healthcare workers without external heat-sealing equipment. Used in clinical settings to contain devices during STERRAD® hydrogen peroxide (H2O2) gas plasma sterilization cycles. The pouch allows sterilant penetration while maintaining a microbial barrier post-sterilization. Healthcare providers use the pouches to ensure device sterility until point-of-use. The device benefits patients by providing a validated, sterile barrier for surgical instruments, reducing infection risk.

Clinical Evidence

No clinical data. Bench testing only. Testing included dye migration (ASTM F1929), tensile strength (ASTM F88), cytotoxicity (ISO 10993-5), microbial aerosol challenge (AAMI TIR12), and sterilization penetration (6-log reduction of Geobacillus stearothermophilus). Accelerated aging (3 years) and 365-day sterility maintenance studies confirmed package integrity and sterility maintenance post-sterilization.

Technological Characteristics

Materials: Tyvek® backing and BOPET/PE transparent film. Construction: Heat-sealed on three sides, self-sealing adhesive strip on the fourth. Sterilization: H2O2 gas plasma (STERRAD®). Standards: ASTM F1929, ASTM F88, ISO 11607, ISO 10993. Connectivity: None. Software: None.

Indications for Use

Indicated for healthcare workers to enclose medical devices for sterilization in STERRAD® Sterilizer Systems (NX Standard, NX Advanced, 100NX Duo, 100NX Flex, 100NX Standard). Supports single-use, terminal sterilization of devices with specific weight, lumen count (max 1), lumen ID (1-2mm), and lumen length (up to 850mm) limits. Maintains sterility for up to 1 year post-sterilization.

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

Steriking® LT-Blueline Pouches with Tyvek® (K221377)

Related Devices

K221377 — SteriKing LT-Blueline Pouches with Tyvek · Wipak OY · Dec 22, 2022
K231996 — Steriking® LT-Blueline Pouches with Tyvek® · Wipak OY · Sep 7, 2023
K221379 — Steriking LT-Blueline Pouches with Tyvek · Wipak OY · Jan 4, 2023
K123162 — U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL · U&U Medical Technology Co, Ltd. · Feb 26, 2014
K133838 — STERILIZATION POUCH/ROLL MADE WITH TYVEK · Sigma Medical Supplies Corp. · Mar 11, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ September 7, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Wipak OY % Amanda Singleton Consultant Compliance Systems International LLC 39 Lockhart Circle Amherst, New York 14228 Re: K231999 Trade/Device Name: Steriking® LT-Blueline Pouches with Tyvek® Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: August 11, 2023 Received: August 11, 2023 ## Dear Amanda Singleton: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by Eileen Cadel -S Eileen Cadel -S Date: for 2023.09.07 13:49:47 -04'00' Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) ### K231999 #### Device Name Steriking® LT-Blueline Pouches with Tyvek® #### Indications for Use (Describe) Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® Sterilizer Systems. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 years post sterilization. The products are for single use only. The Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERRAD® Sterilization Cycles: NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard Max weights: NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 380 mm, .094 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.194 pounds. NX Advanced Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 380 mm, .096 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.224 pounds. 100NX Duo Cycle: For pouch sizes 90 x 200 mm. 90 x 250 mm. 130 x 380 mm. .116 lbs. For pouch sizes 190 x 330 mm. 250 x 400 mm, 300 x 450 mm, 1.222 pounds. 100NX Flex Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.220 pounds. 100NX Standard Cycle: For pouch sizes 90 x 200 mm. 90 x 250 mm. 130 x 380 mm. .202 lbs. For pouch sizes 190 x 330 mm. 250 x 400 mm. 300 x 450 mm. 4.478 pounds. Max Count of lumens: 1 lumen max for All cycles Max ID of lumens: NX Standard Cycle: 1 mm ID for all pouch sizes NX Advanced Cycle: 2 mm ID for all pouch sizes {3}------------------------------------------------ 100NX Cycle: 1 mm ID for all pouch sizes 100NX Flex Cycle: 1 mm ID for all pouch sizes 100NX Standard Cycle: 2 mm ID for all pouch sizes Max lumen lengths: NX Standard Cycle: For pouch sizes 90 x 200 mm. 90 x 250 mm. 130 x 380 mm. 125 mm. For pouch sizes 190 x 330 mm. 250 x 400 mm, 300 x 450 mm, 250 mm. NX Advanced Cycle: For pouch sizes 90 x 200 mm. 90 x 250 mm. 130 x 380 mm. 125 mm. For pouch sizes 190 x 330 mm. 250 x 400 mm, 300 x 450 mm, 250 mm. 100NX Duo Cycle: 850 mm for all pouch sizes 100NX Flex Cycle: 850 mm for all pouch sizes 100NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm. Pouch Sizes: 300 x 450 mm 250 x 400 mm 190 x 330 mm 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # K231999 510(k) Summary (in accordance with 21CFR807.92) | 510K Summary Elements per 21CFR807.92 | Summary | |--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's name, address, telephone number, a contact person, and the date the summary was prepared | Wipak Oy Wipaktie 2 Nastola Finland Contact: Hanna Marttila Phone: +358 (0)40 124 0290 Date prepared: September 6, 2023 Submitter: Amanda Singleton, Compliance Systems International, 716.440.7364 | | Name of the device including the trade or proprietary name if applicable | Proprietary Name: Steriking® LT-Blueline Pouches with Tyvek® | | Common or usual name | Common Name: Peel Pouch | | Classification name | Classification Name: Sterilization wrap | | Classification Product Code | FRG | | Device Classification | Class II | | Regulation Number | 21 CFR 880.6850 | | Identification of the legally marketed device to which the submitter claims equivalence (Primary Predicate device) | K221377 -Steriking® LT-Blueline Pouches with Tyvek® | | Description of the device | Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to contain medical devices to be terminally sterilized in the STERRAD® Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERRAD ® Sterilization System. Sterilization Cycles are noted below. After completion of the sterilization process, the Pouch maintains sterility of the enclosed medical devices until the seal is opened. These pouches are made from a plastic film and Tyvek that is heat-sealed on three sides. The fourth side is left opened and will be self-sealed when used. Steriking® LT-Blueline Pouches with Tyvek® are intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only. The pouches are constructed from Tyvek®/plastic films. The self-sealed pouches are self sealed prior to processing in the STERRAD® Sterilization Systems. Sterilization Systems: STERRAD® Cycles: NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard | | Indications for Use | Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® Sterilizer Systems. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 years post sterilization. The products are for single use only. The Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERRAD® Sterilization Cycles: NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard Max weights: NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .094 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.194 pounds. NX Advanced Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .096 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.224 pounds. 100NX Duo Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .116 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.222 pounds. 100NX Flex Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.220 pounds. 100NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 4.478 pounds. Max Count of lumens: 1 lumen max for All cycles Max ID of lumens: NX Standard Cycle: 1 mm ID for all pouch sizes NX Advanced Cycle: 2 mm ID for all pouch sizes 100NX Standard Cycle: 1 mm ID for all pouch sizes | {5}------------------------------------------------ {6}------------------------------------------------ | Technological Characteristics Comparison Table | | | | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Submission Device – K231999 Steriking® LT-Blueline Pouches with Tyvek® | Comparison | Primary Predicate Device – K221377 Steriking® LT-Blueline Pouches with Tyvek® | | Device Classification | Class II | Same | Class II | | Classification Name | Sterilization wrap | Same | Sterilization wrap | | Regulation Name | 21 CFR 880.6850 | Same | 21 CFR 880.6850 | | Product Code | FRG | Same | FRG | | Indications for Use | Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® | Different | The Steriking® LT-Blueline Pouches with Tyvek are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the | {7}------------------------------------------------ | | | | Pouch Sizes: | | Pouch Sizes: | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterilizer Systems. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 years post sterilization. The products are for single use only. The Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERRAD® Sterilization Cycles: NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard | STERRAD® Sterilizer Systems. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only The Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERRAD® Sterilization Cycles: NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard | | 300 x 450 mm | | 250 mm x 390 mm | | Max weights: NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .094 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.194 pounds. | Max weights: NX Standard Cycle: 75 mm x 200 mm, 100 mm x 250 mm, 150 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .088 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.382 pounds | | 250 x 400 mm | | 205 mm x 390 mm | | NX Advanced Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .096 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.224 pounds. | NX Advanced Cycle: 75 mm x 200 mm, 100 mm x 250 mm, 150 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .084 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.393 pounds | | 190 x 330 mm | | 160 mm x 600 mm | | 100NX Duo Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .116 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.222 pounds. | 100NX Duo Cycle: 75 mm x 200 mm, 100 mm x 250 mm, 150 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .104 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds | | 130 x 380 mm | | 160 mm x 440 mm | | 100NX Flex Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.220 pounds. | 100NX Flex Cycle: | | 130 x 270 mm | | 150 mm x 300 mm | | 100NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 | | | 90 x 250 mm | | 100 mm x 250 mm | | 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 4.478 pounds. | 75 mm x 200 mm, 100 mm x 250 mm, 150 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .158 pounds | | 90 x 200 mm | | 75 mm x 200 mm | | Max Count of lumens: 1 lumen max for All cycles | 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds | Design | These pouches are made from a plastic film and Tyvek that is heat sealed on three sides. The fourth side is left opened and will be self-sealed when used. | | These pouches are made from a plastic film and Tyvek that is heat sealed on three sides. The fourth side is left opened and will be heat-sealed when used. | | Max ID of lumens: | 100NX Standard Cycle: | Backing Material | Tyvek® | No Change | Tyvek® | | NX Standard Cycle: 1 mm ID for all pouch sizes | 75 mm x 200 mm, 100 mm x 250 mm, 150 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .158 pounds | Transparent Film | BOPET/PE | No Change | BOPET/PE | | NX Advanced Cycle: 2 mm ID for all pouch sizes | 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 4.476 pounds | Sterilization Processes | H2O2 Sterilization Process as per: STERRAD® NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard | No Change | H2O2 Sterilization Process as per: STERRAD® NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard | | 100NX Cycle: 1 mm ID for all pouch sizes | Max lumens: 1 mm min ID and Max 1 lumen for all cycles | Sterilant Validation | Achieved a 10-6 Sterility Assurance Level (SAL) of Geobacillus stearothermophilus. NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard | No Change | Achieved a 10-6 Sterility Assurance Level (SAL) of Geobacillus stearothermophilus. NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard | | 100NX Flex Cycle: 1 mm ID for all pouch sizes | NX Standard Cycle: For pouch sizes 250x500mm, 250x390mm 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes. | Package Integrity | Pass | No Change | Pass | | 100NX Standard Cycle: 2 mm ID for all pouch sizes | NX Advanced Cycle: For pouch sizes 250x500mm, 250x390mm 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes. | Biocompatibility | Pass | No Change | Pass | | Max lumen lengths: NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm. | 100NX Duo Cycle: For pouch sizes 250x500mm, 250x390mm 205x390mm is 875 mm max length. Max length is 850 mm for all other pouch sizes. | Shelf-Life Pre-Sterilization | 3 years | Different | 5 years | | NX Advanced Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm. | 100NX Flex Cycle: Max length is 850 mm for all pouch sizes. | Maintenance of Sterility | 1 year | Different | 3 years | | 100NX Duo Cycle: 850 mm for all pouch sizes | 100NX Standard Cycle: For pouch sizes 250x500mm, 250x390mm, 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes. | | | | | | 100NX Flex Cycle: 850 mm for all pouch sizes | Pouch Sizes: 250 mm x 500 mm | | | | | | 100NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm. | | | | | | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ | Max weights | | | | | | Different | | | | | | |----------------------|-------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------------------------------------------------------|------------------------|----------------------------|--------------|-------------------------|-------------------------|-----------------------|------------------------|----------------------------| | Pouch size | NX Advanced Cycle | NX Standard Cycle | 100NX Duo Cycle | 100NX Flex Cycle | 100NX Standard Cycle | Pouch size | NX Advanced Cycle | NX Standard Cycle | 100NX Duo Cycle | 100NX Flex Cycle | 100NX Standard Cycle | | 300 x 450 mm | 1.224 | 1.194 | 1.222 | 1.220 | 4.748 | 250 x 500 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | | 250 x 400 mm | 1.224 | 1.194 | 1.222 | 1.220 | 4.748 | 250 x 390 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | | 190 x 330 mm | 1.224 | 1.194 | 1.222 | 1.220 | 4.748 | 205 x 390 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | | 130 x 380 mm | 0.096 | 0.094 | 0.116 | 0.202 | 0.202 | 160 x 600 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | | 130 x 270 mm | 0.096 | 0.094 | 0.116 | 0.202 | 0.202 | 160 x 440 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | | 90 x 250 mm | 0.096 | 0.094 | 0.116 | 0.202 | 0.202 | 150 x 300 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | | 90 x 200 mm | 0.096 | 0.094 | 0.116 | 0.202 | 0.202 | 100 x 250 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | | | | | | | | 75 x 200 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | | Max Lumen Dimensions | Max Count of lumens: | Different | 1 mm min ID Lumen and Max 1 lumen for all cycles | | | | | | | | | | | 1 lumen max for all pouch sizes | | | | | | | | | | | | | | | | | | | | | | | | | | Max lumen Id: | | For NX Standard Cycle: For pouch sizes 250x500mm, 250x390mm, 205x390mm is 125 mm max length. Max | | | | | | | | | | | | | | | | | | | | | | | | NX Standard: | | | | | | | | | | | | | 1 mm ID for all pouch sizes | | length is 50 mm for all other pouch sizes. | | | | | | | | | | | | | | | | | | | | | | | | NX Advanced: | | NX Advanced Cycle: For pouch | | | | | | | | | | | 2 mm ID for all pouch sizes | | sizes 250x500mm, 250x390mm, 205x390mm is 125 mm max | | | | | | | | | | | | | length. Max length is 50 mm for | | | | | | | | | | | 100NX Duo: | | all other pouch sizes. | | | | | | | | | | | 1 mm ID for all pouch sizes | | | | | | | | | | | | | | | 100NX Duo Cycle: For pouch | | | | | | | | | | | 100NX Flex: | | sizes 250x500mm, 250x390mm, | | | | | | | | | | | 1 mm ID for all pouch sizes | | 205x390mm is 875 mm max | | | | | | | | | | | | | length. Max length is 850 mm | | | | | | | | | | | 100NX Standard: | | for all other pouch sizes. | | | | | | | | | | | 2 mm ID for all pouch sizes | | | | | | | | | | | | | | | 100NX Flex Cycle: Max length | | | | | | | | | | | Max lumen lengths: | | is 850 mm for all pouch sizes. | | | | | | | | | | | | | | | | | | | | | | | | NX Standard Cycle: | | 100NX Standard Cycle: For pouch | | | | | | | | | | | For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. | | sizes 250x500mm, 250x390mm, | | | | | | | | | | | | | 205x390mm is 125 mm max | | | | | | | | | | | For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm. | | length. Max length is 50 mm for all | | | | | | | | | | | | | other pouch sizes. | | | | | | | | | | | | | | | | | | | | | | | | NX Advanced Cycle: | | | | | | | | | | | | | For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x<br…

Steriking® LT-Blueline Pouches with Tyvek®

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Steriking® LT-Blueline Pouches with Tyvek®

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