Identity
- Trade Name
- The Venous Assist System FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Device Name
- Sequential compression pump only FDA UDI
- Model / Reference
- DVT-2600 FDA UDI
- Description
- Sequential compression pump only FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315678384 FDA UDI
- 510(k) Number
- K112677 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Sequential venous compression system inflator 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sequential venous compression system inflatorIntermittent venous compression system pump
The Venous Assist System by Daesung Maref Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intermittent venous compression system pump.
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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(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.
- The Venous Assist System(DVT-2600) — DAESUNG MAREF CO., LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Daesung Maref Co., Ltd.
Sources (1)
- FDA UDI 3f84747a-ffeb-46c5-b48d-12d6a907a6e9 34 fields · synced May 30, 2026