Duns Number:688817949
Device Description: 1chamber oxford foot garment (One size)
Catalog Number
-
Brand Name
The Venous Assist System(DVT-2600)
Version/Model Number
DS131
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112677,K112677,K112677,K112677,K112677
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
06141a13-b294-4fb6-8d31-af6bfce42b26
Public Version Date
June 24, 2021
Public Version Number
5
DI Record Publish Date
October 18, 2016
Package DI Number
38809315678811
Quantity per Package
4
Contains DI Package
18809315678817
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 |