AccessGUDID - DEVICE: Venowave VW5 (00627843553601)

GUDID

Device Identifier (DI) Information

Brand Name: Venowave VW5
Version or Model: VW5-6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Therma Bright Inc

Primary DI Number: 00627843553601
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200775422 *Terms of Use
Previous DI: 00683601000053

Device Description: The Venowave VW5 series comprises compact, battery-operated non-pneumatic, non-sequential, peristaltic wave compression pumps designed to generate wave-form motion. When securely fastened below the knee on the calf, these pumps create compression, leading to an increased upward volumetric displacement of venous and lymph fluid. The device is used for Management of the symptoms of post thrombolytic syndrome (PTS), Prevention of deep vein thrombosis (DVT), Prevention of primary thrombosis, Treatment of lymphedema, Diminishing post-operative pain and swelling, Treatment of leg swelling due to vascular insufficiency, Treatment of varicose veins Treatment of chronic venous insufficiency.

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?
63558	Wearable sequential venous compression system	A noninvasive, electrically-powered, entirely patient-worn device assembly intended to improve venous and lymphatic return from the leg to help treat/prevent venous disorders/sequelae (e.g., swelling, pain, thrombosis). It consists of an electronic processor with a compressing mechanism (e.g., pump, contracting straps) intended to be strapped to the calf, which provides a continuous peristaltic wave motion, and used for prescribed periods of treatment. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for hospitalized/institutionalized patients.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOW	Sleeve, Limb, Compressible

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232640	000

Device Exempt from Premarket Submission: No 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
Weight: 270 Gram
Length: 190 Millimeter
Width: 100 Millimeter
Height: 48 Millimeter

Device Record Status

Public Device Record Key: 3e9ca9e9-2fe2-45d5-aa79-c2a51f9e8522
Public Version Date: October 25, 2024
Public Version Number: 1
DI Record Publish Date: October 17, 2024