Duns Number:062312574
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
BP3MW1-4YCVS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
f4920e6f-d72c-4f73-9efa-f39a3bd76fc3
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
January 19, 2018
Package DI Number
10050428264147
Quantity per Package
6
Contains DI Package
00050428264140
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON PACKAGE
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 |