Duns Number:047025993
Device Description: Blood Pressure Monitor Replacement Cuffs Medium
Catalog Number
-
Brand Name
Vive Precision
Version/Model Number
DMD1038GRYM
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
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
346552b6-f55b-44ce-a368-9aa8e0b76b17
Public Version Date
July 22, 2019
Public Version Number
2
DI Record Publish Date
September 13, 2018
Package DI Number
10818323024637
Quantity per Package
100
Contains DI Package
00818323024630
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |