Duns Number:062312574
Device Description: CB8 Digital Pregnancy Stick CVS DPS Digital Early (ER)
Catalog Number
-
Brand Name
CVS Health Digital Pregnancy Test
Version/Model Number
CB8
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 27, 2019
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
K060128,K060128,K060128
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
eaad4bc6-f133-4144-b576-d2370d60aa08
Public Version Date
September 30, 2019
Public Version Number
4
DI Record Publish Date
June 30, 2016
Package DI Number
10050428255442
Quantity per Package
24
Contains DI Package
00050428255445
Package Discontinue Date
September 27, 2019
Package Status
Not 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |