Duns Number:002111896
Device Description: Reusable Cuff, Single Tube, Lg Adult/Thigh, HP Fit
Catalog Number
CUG-US3860HP
Brand Name
Vermed
Version/Model Number
CUG-US3860HP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K063863
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
20c3d9e4-62ed-4688-82d7-8237be029ff8
Public Version Date
July 22, 2019
Public Version Number
4
DI Record Publish Date
January 02, 2017
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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |