venowave

Basic Information

• Brand Name: venowave
• Primary DI: 00683601000053
• Version / Model: vw5-6m
• Company Name: Saringer Life Science Technologies Inc
• Labeler DUNS: 243385601
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2018-08-09
• Public Version Status: Update
• Public Device Record Key: cebb1813-0d2b-4099-9bd9-a74ce2405064
• Distribution End Date: 2018-08-08

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOW	Sleeve, Limb, Compressible	Cardiovascular	870.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00683601000053	GS1
Package	30683601000054	GS1		2	Not in Commercial Distribution	2018-08-08
Package	10683601000050	GS1		10	Not in Commercial Distribution	2018-08-08
Package	20683601000057	GS1		20	Not in Commercial Distribution	2018-08-08

Customer Contacts

• Phone: [phone]
• Email: [email protected]