Duns Number:175899459
Device Description: DVT GARMENT VENAFLOW ELITE STANDARD CALF CUFF
Catalog Number
AIR3040
Brand Name
NA
Version/Model Number
AIR3040
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 17, 2019
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
K012597,K012597
Product Code
JOW
Product Code Name
SLEEVE, LIMB, COMPRESSIBLE
Public Device Record Key
c47dde33-13e6-4e50-939a-458173e6c838
Public Version Date
April 17, 2019
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
20888551004975
Quantity per Package
5
Contains DI Package
10888551004978
Package Discontinue Date
April 17, 2019
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2763 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1372 |
| U | Unclassified | 20 |