Identity
- Trade Name
- Fluido® Compact Warming Module EUDAMEDFluido® Compact FDA UDI
- Generic Name
- Conduction blood/fluid warmer FDA UDI
- Device Name
- Fluido® Compact Warming Module EUDAMEDFDA UDI
- Model / Reference
- 650200 EUDAMEDWarming Module FDA UDI
- Description
- Fluido® Compact Warming Module FDA UDI
Identifiers
- Catalog Number
- 650200 FDA UDI
- Primary DI / UDI-DI
- 18719867001561 EUDAMEDFDA UDI
- Basic UDI-DI
- B-18719867001561 EUDAMED
- 510(k) Number
- K211618 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- EMDN Code
- Z12030305 INFUSION HEATERS EUDAMED
- GMDN Term
- Conduction blood/fluid warmer FDA UDI
Classification
- Device Class
- Class IIb 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Fluido® Compact Warming Module by The Surgical Company International B.V. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-18719867001561 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- The Surgical Company International B.V.
- EUDAMED SRN
- NL-MF-000001973
Sources (2)
- EUDAMED 0962fb3b-17a0-461a-be66-47125c6c3a7c 61 fields · synced Jun 18, 2026
- FDA UDI 1e65c580-d5c6-479b-a182-0a8a31b61f9f 35 fields · synced May 30, 2026