Duns Number:078497467
Device Description: Beurer Fertility Convenience Kit with Pearl AppEach kit contains:15 FSH test strips,15 LH Beurer Fertility Convenience Kit with Pearl AppEach kit contains:15 FSH test strips,15 LH test strips,2 hCG test strips (pregnancy test),Access (activation code) for the Pearl Fertility App.
Catalog Number
792.97
Brand Name
Beurer
Version/Model Number
OT80
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
Yes
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
-
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
0eb3364c-02e7-4473-b482-c791821499c8
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 01, 2021
Package DI Number
10850003500475
Quantity per Package
12
Contains DI Package
00850003500478
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |
| U | Unclassified | 2 |