Duns Number:342751189
Device Description: Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth
Catalog Number
-
Brand Name
Clue
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193330
Product Code
PYT
Product Code Name
Device, Fertility Diagnostic, Contraceptive, Software Application
Public Device Record Key
85c5884e-1251-4f85-b380-756222501bcf
Public Version Date
April 18, 2022
Public Version Number
1
DI Record Publish Date
April 08, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |