venowave

Primary DI
00683601000053
Brand
venowave
Company
Saringer Life Science Technologies Inc
Model
vw5-6m
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.
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10683601000050PackageGS110Not in Commercial Distribution
20683601000057PackageGS120Not in Commercial Distribution
30683601000054PackageGS12Not in Commercial Distribution
00683601000053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068360100005010683601000050
2068360100005720683601000057
3068360100005430683601000054
00683601000053006836010000536836010000530683601000053

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression systemA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9056400060christine@saringer.com

Regulatory Flags#

DUNS number
243385601
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00683601000060ice o therm procontrast2017-09-25
00683601000077ice o therm procold2017-12-29
00683601000022venowavevw5-10vw5-10 case of 2 units2016-09-21

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