AccessGUDID - DEVICE: Proov (00850035206164)

GUDID

Device Identifier (DI) Information

Brand Name: Proov
Version or Model: Fertility 4-in-1 Test
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mfb Fertility, Inc.

Primary DI Number: 00850035206164
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080270263 *Terms of Use

Device Description: A comprehensive screening kit that analyzes key hormone factors related to fertility. Contains 3 FSH urine tests to check ovarian reserve, 10 LH tests to predict ovulation during the fertile window, 5 PdG tests to confirm ovulation during the implantation window, 2 hCG urine tests to aid in early detection of pregnancy.

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
JHI	Visual, Pregnancy Hcg, Prescription Use
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter
QKE	Immunoassay, Pregnanediol Glucuronide, Over The Counter
NGE	Test, Luteinizing Hormone (Lh), Over The Counter
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter

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: 8a4df408-b0ab-493a-8a7e-be2ed1daf0ef
Public Version Date: May 25, 2023
Public Version Number: 1
DI Record Publish Date: May 17, 2023