Duns Number:544328369
Device Description: Home use Reusable D-ring cuff,M(22-36CM)
Catalog Number
-
Brand Name
Vistarmed
Version/Model Number
VD-002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 22, 2022
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152468
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
2bf510e8-d64b-49f2-be63-a1e1b85a8e37
Public Version Date
March 02, 2022
Public Version Number
1
DI Record Publish Date
February 22, 2022
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 243 |