Identity
- Trade Name
- The Venous Assist System(DVT-2600) FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, single-use FDA UDI
- Device Name
- 3chamber non-woven thigh garment (Medium size) FDA UDI
- Model / Reference
- DS012 FDA UDI
- Description
- 3chamber non-woven thigh garment (Medium size) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315678438 FDA UDI
- 510(k) Number
- K112677 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Multi-chamber venous compression system garment, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-chamber venous compression system garment, single-use
The Venous Assist System(DVT-2600) by Daesung Maref Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multi-chamber venous compression system garment, single-use.
- Albahealth — Albahealth, LLC · Class II
- Albahealth — Albahealth, LLC · Class II
- Kendall SCD — Cardinalhealth · Class II
- Kendall SCD — Cardinal Health 200, LLC · Class II
- VasoGrad — Compression Therapy Concepts · Class II
- A-V Impulse — Cardinalhealth · Class II
- Albahealth — Albahealth, LLC · Class II
- Kendall SCD — Cardinalhealth · Class II
Cleared under the same submission
K112677 also covers:
- Compressible Limb Therapy System(LX7(V7)) — DAESUNG MAREF CO., LTD.
- The Venous Assist System — DAESUNG MAREF CO., LTD.
- The Venous Assist System — DAESUNG MAREF CO., LTD.
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD.
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD.
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD.
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD.
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD.
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD.
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD.
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD.
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Daesung Maref Co., Ltd.
Sources (2)
- FDA UDI ae15f2e5-ecee-4b1a-8ae0-3e25ac0ba1c9 34 fields · synced Jun 9, 2026
- EUDAMED 1 fields · synced May 22, 2026