BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)

K960525 · Bemis Mfg. Co. · MMK · Mar 28, 1996 · General Hospital

Device Facts

• Record ID: K960525
• Device Name: BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)
• Applicant: Bemis Mfg. Co.
• Product Code: MMK · General Hospital
• Decision Date: Mar 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Bemis One Quart Phlebotomy Container is a sharps disposal container. It is intended for the safe disposal of needles and syringes in areas with or without controlled access. They are typically used in patient rooms, nurse’s stations, doctors’ and dentists’ offices and on med carts.

Device Story

One quart capacity sharps disposal container; injection-molded polypropylene; translucent red; puncture-resistant; leakproof sides/bottom. Features lid with two openings for blood collection needles and larger sharps (e.g., butterfly needles); includes 'needle key' for unscrewing needles from tube holders. Labeled with biohazard symbol per OSHA. Secured to surfaces via adhesive-backed plastic base. Used in patient rooms, nurse stations, and medical carts by healthcare staff for safe disposal of sharps. Prevents accidental injury during disposal process.

Clinical Evidence

Bench testing only. Performance testing confirmed compliance with impact resistance, puncture resistance, overfill detection, leak resistance, sharps access/closure, stability, and handling requirements.

Technological Characteristics

Material: Polypropylene plastic; 0.070" wall thickness. Dimensions: 8"H x 4.3"W x 4.3"D. Volume: 1.0 qt. Features: Injection-molded, puncture-resistant, leakproof, biohazard labeling, adhesive-backed base for surface mounting, needle-unscrewing key, dual-opening lid with temporary and final locking closures.

Indications for Use

Indicated for the safe disposal of needles and syringes in clinical settings including patient rooms, nurse stations, and medical offices.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Bemis Phlebotomy Container

Submission Summary (Full Text)

{0}

K960525

# 510 (k) SUMMARY

| **Submitter’s Name:** Bemis Health Care | MAR 28 1996 |
| --- | --- |
| **Address:** 300 Mill Street
Sheboygan Falls, WI 53085 | |
| **Telephone:** 414-467-4621 | |
| **Contact Person:** John B. Howell | |
| **Date Submitted:** January 17 1996 | |

## Name of Device

- **Common Name:** Sharps Disposal Container
- **Trade name:** *Bemis One Quart Phlebotomy Container*
- **Classification Name:** Sharps Disposal Container
- **Predicate Device:** Bemis Phlebotomy Container

## Description of the Device

The One Quart Phlebotomy Container has a volume of 1.0 qt. and weigh .0.2 lb (3.2oz.) with dimensions of 8"H x 4.3"W x 4.3"D. One Quart Phlebotomy Containers are injection molded with polypropylene plastic in translucent red. These products are typically a .070" wall thickness. The One Quart Phlebotomy containers are NOT reusable.

The One Quart Phlebotomy Containers are puncture-resistant, injection-molded containers with integral sidewalls and bottom. They are leakproof on the sides and bottom.

They are labeled with the Biohazard warning symbol. The label color is orange-red, with lettering and symbol in contrasting color in accordance with OSHA regulations. The labels are attached directly to the surface of the container by a permanent adhesive.

The One Quart Phlebotomy Container is secured to a tray or table top in an adhesive-backed injection molded plastic base.

There are no features to bend, break, or shear the needle.

The lid incorporates a "needle key" which can be used to unscrew needles from blood collection tube holders. After blood collection, the needle is inserted into the slotted opening and slid forward until firmly seated, and turned to unscrew the needle from the tube holder.

The lid has two openings: one intended to accommodate blood tube needles only and the other, larger opening to accept larger sharps such as butterfly needles. Both openings have covers that may be temporarily closed during transportation. Each cover also has a tab that is inserted in slots for final locking closure for disposal.

## Statement of intended use

The Bemis One Quart Phlebotomy Container is a sharps disposal container. It is intended for the safe disposal of needles and syringes in areas with or without controlled access. They are typically used in patient rooms, nurse’s stations, doctors’ and dentists’ offices and on med carts.

{1}

K960525

# COMPARISON TO PREDICATE DEVICE

## Bemis One Quart Phlebotomy Container
## Equivalent: Bemis Phlebotomy

| Impact Resistance:
PASS | Impact Resistance:
PASS |
| --- | --- |
| Puncture Resistance:
PASS | Puncture Resistance:
PASS |
| Overfill Detection:
PASS | Overfill Detection:
FAIL |
| Leak Resistance:
PASS | Leak Resistance:
PASS |
| Sharps Access and Closure:
PASS | Sharps Access and Closure:
PASS |
| Stability in Upright Position:
PASS | Stability in Upright Position:
PASS |
| Handling:
PASS | Handling:
PASS |
| Capacity:
1qt. | Capacity:
0.5 qt. |
| Feature to Minimize Aerosolization:
Two lids with temporary snap closure | Feature to Minimize
Aerosolization:
Slide Top |

## Conclusion

The conclusion drawn from our testing is that the Bemis One Quart Phlebotomy Container is as safe and effective as the legally marketed Bemis Phlebotomy Container.