AccessGUDID - DEVICE: CVS Health (00634188000967)

GUDID

Device Identifier (DI) Information

Brand Name: CVS Health
Version or Model: 882127
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 882127
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Primary DI Number: 00634188000967
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062312574 *Terms of Use

Device Description: Safe containment with optional return & disposal (additional fees may apply). System Includes: needle container, shipping box approved by the US Postal Service (additional fees may apply), instructions for use. Contents: 1 shipping box; 1 sharps container; syringe capacity: up to 70 1cc & 30 3cc syringes or 300 pen needles. Needle/sharps container. Disposal mailing box approved by the US Postal Service. CVS/pharmacy Needle Collection & Disposal System allows you to safely contain and store syringes, pen needles and needles. CVS quality. Made in the USA.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35429	Sharps container	A hard-walled container designed for the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically by incineration.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMK	Container, Sharps

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K945275	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 441b11dd-7c4d-4bb0-935b-c00326bb6a66
Public Version Date: August 18, 2023
Public Version Number: 4
DI Record Publish Date: September 12, 2016