Duns Number:105932508
Device Description: Replacement Cuff, Black Nylon, Adult, with D-Ring and Chest-piece Attached for Self Taking Replacement Cuff, Black Nylon, Adult, with D-Ring and Chest-piece Attached for Self Taking Sphygmomanometers.
Catalog Number
-
Brand Name
BV Medical
Version/Model Number
21-072-014-ST
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
184ab47d-e1e1-413d-b89a-2e54f4c1ae46
Public Version Date
July 22, 2019
Public Version Number
2
DI Record Publish Date
April 12, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 658 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 163 |