Identity
- Trade Name
- ULPA Box Filter FDA UDI
- Generic Name
- Surgical plume evacuation system FDA UDI
- Device Name
- SAFEGUARD BLUE® Hydrophobic ULPA Filter with Built-in Fluid Trap EUDAMED
- Model / Reference
- ICM-000-0276 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817688021650 EUDAMEDFDA UDI
- Basic UDI-DI
- 081768802SmokeEvacFiltrGG EUDAMED
- FDA Product Code
- FYD FDA UDI
- EMDN Code
- Z12019004 SURGICAL SMOKE EVACUATION SYSTEMS EUDAMED
- GMDN Term
- Surgical plume evacuation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5070 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical plume evacuation system
ULPA Box Filter by I.C. Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- I.C. Medical, Inc.
Sources (2)
- FDA UDI b5783260-3034-4727-b2d0-5535e0bad4a5 32 fields · synced Jul 13, 2026
- EUDAMED ad424135-e0d1-47d8-9910-6fff38851049 61 fields · synced Jul 13, 2026