Duns Number:062312574
Device Description: Blood Pressure Monitor
Catalog Number
Type BM35/1
Brand Name
CVS Health
Version/Model Number
800231
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
-
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
fedcab06-86f4-42f6-9a54-39ab95652b6d
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
February 24, 2017
Package DI Number
10050428283926
Quantity per Package
12
Contains DI Package
00050428283929
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
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 |