AccessGUDID - DEVICE: CVS Health Moisturizing Vaginal Suppositories (M7138333060)

GUDID

Device Identifier (DI) Information

Brand Name: CVS Health Moisturizing Vaginal Suppositories
Version or Model: 833306
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FIDIA FARMACEUTICI SPA

Primary DI Number: M7138333060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428453013 *Terms of Use

Device Description: CVS Health™ Moisturizing Vaginal Suppositories are a non-hormonal moisturizer delivered in an easy-to-use suppository format. CVS Health™ Moisturizing Vaginal Suppositories, intended for the temporary relief of vaginal dryness symptoms, moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
34131	Vaginal lubricant	A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUC	Lubricant, Personal

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
Storage Environment Temperature: between 33 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd6db258-df7a-41b1-8976-8ae43e7665c3
Public Version Date: September 23, 2022
Public Version Number: 1
DI Record Publish Date: September 15, 2022