Venowave VW5
- Primary DI
- 00627843553601
- Brand
- Venowave VW5
- Company
- Therma Bright Inc
- Model
- VW5-6
- 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.
- Published
- 2024-10-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| JOW | Sleeve, Limb, Compressible |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JOW | Sleeve, Limb, Compressible | Cardiovascular | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K232640 | 000 | Venowave VW5 | Thermabright | 2024-06-25 | JOW |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00627843553595 | Package | GS1 | 20 | In Commercial Distribution |
| 00683601000053 | Previous | GS1 | 0 | |
| 00627843553601 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00627843553595 | 00627843553595 | 627843553595 | 0627843553595 |
| 00683601000053 | 00683601000053 | 683601000053 | 0683601000053 |
| 00627843553601 | 00627843553601 | 627843553601 | 0627843553601 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
| Type | Value | Unit |
|---|
| Height | 48 | Millimeter |
| Length | 190 | Millimeter |
| Weight | 270 | Gram |
| Width | 100 | Millimeter |
Regulatory Flags
- DUNS number
- 200775422
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
| 04719893351026 | Wellell | Wellell Inc. | JOW | 2026-03-17 |
| 00812311022363 | BIOARTERIAL+ | Bio Compression Systems, Inc | JOW | 2026-03-09 |
| 00850033615272 | ThermoTek WRAP, DVT, CALF SET, PUSH, SPU | THERMOTEK, INC. | JOW | 2026-02-21 |
| 00850033615494 | ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTN | THERMOTEK, INC. | JOW | 2026-02-21 |
| 00812311022479 | Bio Arterial Deluxe | Bio Compression Systems, Inc | JOW | 2026-02-13 |
| 00850001096386 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
| 00850001096393 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
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| 00850001096430 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
| 00850001096447 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
| 00850001096461 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
| 00850001096478 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
| 00850001096485 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
| 00850001096492 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
| 00850001096508 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
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| 00850001096539 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
| 00850001096546 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
| 00850001096553 | Therm-X | ZENITH TECHNICAL INNOVATIONS, LLC | JOW | 2026-02-13 |
| 10885380185120 | Kendall | Cardinal Health 200, LLC | JOW | 2026-02-10 |
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| 18809802648507 | DVT-SERIES | DAESUNG MAREF CO.,LTD. | JOW | 2026-02-09 |
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