Identity
- Trade Name
- DVT-PRO FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Device Name
- Tubing (102cm) [DS310] 1ea [One polybag] FDA UDI
- Model / Reference
- DS310 FDA UDI
- Description
- Tubing (102cm) [DS310] 1ea [One polybag] FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315679909 FDA UDI
- 510(k) Number
- K203353 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sequential venous compression system inflator
Dvt-Pro by Daesung Maref Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203353 also covers:
- DVT-PRO — DAESUNG MAREF CO., LTD.
- DVT-PRO — DAESUNG MAREF CO., LTD.
- DVT-PRO — DAESUNG MAREF CO., LTD.
- DVT-PRO — DAESUNG MAREF CO., LTD.
- DVT-PRO — DAESUNG MAREF CO., LTD.
- DVT-PRO — DAESUNG MAREF CO., LTD.
- DVT-PRO — DAESUNG MAREF CO., LTD.
- DVT-PRO — DAESUNG MAREF CO., LTD.
- DVT-SERIES — 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 33f935b2-2009-4f5c-b02f-1dc30b19e7e3 34 fields · synced May 31, 2026