Identity
- Trade Name
- Fluido® Compact Standard Set EUDAMEDFluido® Compact FDA UDI
- Generic Name
- Conduction blood/fluid warmer set FDA UDI
- Device Name
- Fluido® Compact Standard Set EUDAMEDFDA UDI
- Model / Reference
- 672000 EUDAMEDStandard Set FDA UDI
- Description
- Fluido® Compact Standard Set FDA UDI
Identifiers
- Catalog Number
- 672000 FDA UDI
- Primary DI / UDI-DI
- 18719867001776 EUDAMEDFDA UDI
- Basic UDI-DI
- B-18719867001776 EUDAMED
- 510(k) Number
- K211618 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- EMDN Code
- Z12030385 INFUSION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Conduction blood/fluid warmer set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Fluido® Compact Standard Set by The Surgical Company International B.V. — 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-18719867001776 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- The Surgical Company International B.V.
- EUDAMED SRN
- NL-MF-000001973
Sources (2)
- EUDAMED 74a72174-6635-4a8b-9210-46eafb21d3ce 61 fields · synced Jun 18, 2026
- FDA UDI c747ac0d-9df1-4aaf-a612-7211f74a4b67 35 fields · synced May 30, 2026