DEVICE: Proov (00850035206126)
Device Identifier (DI) Information
Proov
Pregnancy Pack
In Commercial Distribution
Mfb Fertility, Inc.
Pregnancy Pack
In Commercial Distribution
Mfb Fertility, Inc.
At home fertility test that measures all 4 cycle hormones for a comprehensive fertility map.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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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 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ebf45ccf-0cba-4a57-8462-b9ac598f386f
April 05, 2023
1
March 28, 2023
April 05, 2023
1
March 28, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined