(52 days)
Bemis Phlebotomy Container
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No
The device is a simple sharps disposal container made of plastic with mechanical features for needle disposal. There is no mention of any computational or analytical capabilities.
No
This device is a sharps disposal container, intended for the safe disposal of needles and syringes, not for treating any medical condition or disease.
No
This device is a sharps disposal container and is not used to diagnose any medical condition. Its purpose is for the safe disposal of needles and syringes.
No
The device description clearly details a physical container made of injection-molded plastic, indicating it is a hardware device, not software.
Based on the provided information, the Bemis One Quart Phlebotomy Container is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as a "sharps disposal container" for the "safe disposal of needles and syringes." This is a device used for waste management and safety, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical characteristics of the container (material, size, puncture resistance, leakproofness, labeling, lid features for needle disposal), not on any components or functions related to analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample handling for analysis, or any other elements typically associated with IVD devices.
In summary, the Bemis One Quart Phlebotomy Container is a medical device designed for the safe containment and disposal of sharps, which is a different category than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
The One Quart Phlebotomy Container has a volume of 1.0 gt. and weigh .0.2 1b (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 .. 970" 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
typically used in patient rooms, nurse's stations, doctors' and dentists' offices and on med carts.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of the Bemis One Quart Phlebotomy Container to the Bemis Phlebotomy Container on the following criteria: Impact Resistance, Puncture Resistance, Leak Resistance, Sharps Access and Closure, Stability in Upright Position, Handling. The One Quart Phlebotomy Container passed all tests, while the predicate failed Overfill Detection.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bemis Phlebotomy Container
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).
0
510 (k) SUMMARY
| Submitter's Name: | Bemis Health Care |
|---|---|
| Address: | 300 Mill Street |
| Sheboygan Falls, WI 53085 | |
| Telephone: | 414-467-4621 |
| Contact Person: | John B. Howell |
| Date Submitted: | January 17 1996 |
| MAR 28 1996 |
|---|
| ------------- |
Name of Device Common Name: Trade name: Classification Name: Predicate Device:
Sharps Disposal Container Bemis One Quart Phlebotomy Container Sharps Disposal Container Bemis Phlebotomy Container
Description of the Device
The One Quart Phlebotomy Container has a volume of 1.0 gt. and weigh .0.2 1b (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 .. 970" 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
Impact Resistance: PASS
Puncture Resistance: PASS
Overfill Detection: PASS
Leak Resistance: PASS
Sharps Access and Closure: PASS
Stability in Upright Position: PASS
Handling: PASS
Capacity: 1 qt.
Feature to Minimize Aerosolization: Two lids with temporary snap closure
Equivalent: Bemis Phlebotomy
Impact Resistance: PASS
Puncture Resistance: PASS
Overfill Detection: FAIL
Leak Resistance: PASS
Sharps Access and Closure: PASS
Stability in Upright Position: PASS
Handling: PASS
Capacity: 0.5 gt.
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.