AccessGUDID - DEVICE: venowave (00683601000053)

GUDID

Device Identifier (DI) Information

Brand Name: venowave
Version or Model: vw5-6m
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Saringer Life Science Technologies Inc

Primary DI Number: 00683601000053
Issuing Agency: GS1
Commercial Distribution End Date: August 08, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 243385601 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16837	Sequential venous compression system	A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOW	Sleeve, Limb, Compressible

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status
30683601000054	2	00683601000053	2018-08-08	Not in Commercial Distribution
10683601000050	10	30683601000054	2018-08-08	Not in Commercial Distribution
20683601000057	20	00683601000053	2018-08-08	Not in Commercial Distribution