Duns Number:483609579
Device Description: Clearblue Fertility Monitor with touch screen 1ct US
Catalog Number
-
Brand Name
Clearblue
Version/Model Number
Fertility Monitor
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
NGE
Product Code Name
Test, Luteinizing Hormone (Lh), Over The Counter
Public Device Record Key
6060c63f-5b9f-4a83-98e4-7b0a1b8ec2f5
Public Version Date
March 09, 2020
Public Version Number
2
DI Record Publish Date
March 01, 2019
Package DI Number
10633472600224
Quantity per Package
2
Contains DI Package
00633472600227
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |