Duns Number:062312574
Device Description: A convenience kit consisting of 1 CVS Pregnancy Digital Pregnancy Test and 1 CVS Early Res A convenience kit consisting of 1 CVS Pregnancy Digital Pregnancy Test and 1 CVS Early Result Pregnancy Test
Catalog Number
-
Brand Name
CVS Health Digital + Early Result Pregnancy Test Kit
Version/Model Number
CB8 + PLPL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 02, 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
K042280,K060128,K042280,K060128
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
b60bc028-2512-4152-af20-6df269394e6f
Public Version Date
December 03, 2019
Public Version Number
4
DI Record Publish Date
June 30, 2016
Package DI Number
10050428414429
Quantity per Package
24
Contains DI Package
00050428414422
Package Discontinue Date
December 02, 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 |