Duns Number:243385601
Device Description: The VW5 is a peristaltic wave pump driven by a small DC gearmotor and powered by a single The VW5 is a peristaltic wave pump driven by a small DC gearmotor and powered by a single AA battery.The puhttps://gudid.fda.gov/gudid/resources/images/icons/icon_info_small.pngmp assembly is intended for application to the calf of the leg, though in principal, it may be used on other parts of the body. The calf, in particular, is the site where clots can form in the bloodstream, and hence the application of a pump to this site can prevent the formation of these clots by preventing pooling and stagnation of blood in this area. It also prevents accumulation of blood or lymphatic fluids that cause swelling and pain (Post Thrombotic syndrome, PTS) by pumping this area out.
Catalog Number
-
Brand Name
venowave
Version/Model Number
vw5-6m
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 08, 2018
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
-
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
cebb1813-0d2b-4099-9bd9-a74ce2405064
Public Version Date
August 09, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
30683601000054
Quantity per Package
2
Contains DI Package
00683601000053
Package Discontinue Date
August 08, 2018
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |