Duns Number:062312574
Device Description: CB8 CVS DPS Digital Early Result Blue Cap 2 ct
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
Digital Pregnancy Test
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
K060128,K060128,K060128
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
9ffafbd6-8f6b-4899-a760-f72d6913932e
Public Version Date
June 03, 2019
Public Version Number
1
DI Record Publish Date
May 24, 2019
Package DI Number
10050428253950
Quantity per Package
24
Contains DI Package
00050428253953
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| 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 |