AccessGUDID - DEVICE: CVS Pharmacy Inc. (00050428573181)

GUDID

Device Identifier (DI) Information

Brand Name: CVS Pharmacy Inc.
Version or Model: Mix Tampons CVS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Primary DI Number: 00050428573181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062312574 *Terms of Use

Device Description: The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The box contains two types of tampons (18+18) offered in two absorbencies: Regular and Super. Each tampon is individually wrapped with two different color and packaged in multi -unit containers for retail sale. Regular (green wrapper) and Super (pink wrapper). Each tampon is registered in GUDID database with a different Primary DI Number: - Applicator Regular : 00050428516706 - Applicator Super : 00050428513279

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):	Yes
Kit:	Yes
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?
35694	Menstrual tampon, unscented	A non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HEB	Tampon, Menstrual, Unscented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 852de115-5289-4a5e-b072-3dca9e9a5dfa
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: February 15, 2017