Identity
- Trade Name
- Sequential Circulator FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Model / Reference
- SC-2004-DL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812311026248 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812311026248 EUDAMED
- 510(k) Number
- K210417 FDA UDI
- FDA Product Code
- JOW FDA UDI
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
- GMDN Term
- Sequential venous compression system inflator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Sc-2004-Dl by Bio Compression Systems, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00812311026248 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bio Compression Systems, Inc.
- EUDAMED SRN
- US-MF-000008442
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 14d40155-25ad-492f-9993-ac8e3ead0e3b 61 fields · synced Jul 11, 2026
- FDA UDI 7bf67f6b-1459-42b0-ae91-679ce356362e 33 fields · synced May 29, 2026