Duns Number:688817949
Device Description: 3 Chamber calf garment(One size)
Catalog Number
-
Brand Name
The Venous Assist System
Version/Model Number
DS026
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150980,K150980,K150980,K150980
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
c94b6a1c-402b-46b8-9efc-2adfffd87934
Public Version Date
June 24, 2021
Public Version Number
4
DI Record Publish Date
September 06, 2016
Package DI Number
28809315677718
Quantity per Package
50
Contains DI Package
08809315677714
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |