AccessGUDID - DEVICE: Proov (00860002790817)

GUDID

Device Identifier (DI) Information

Brand Name: Proov
Version or Model: Confirm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mfb Fertility, Inc.

Primary DI Number: 00860002790817
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080270263 *Terms of Use

Device Description: Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home.

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?
60862	Natural conception assistance kit	A collection of devices intended to improve the likelihood of natural conception by monitoring ovulation and supplementing essential vitamins. The kit may contain in vitro diagnostic medical devices (IVDs) such as immunochromatographic tests for ovulation and pregnancy detection, a digital thermometer, vitamin supplements for the male and the female, and instructions for use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKE	Immunoassay, Pregnanediol Glucuronide, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191462	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: 9a556f73-b1a7-400f-8715-3f3529ccb1e4
Public Version Date: April 03, 2023
Public Version Number: 1
DI Record Publish Date: March 24, 2023