Identity
- Trade Name
- Fluido® AirGuard System FDA UDI
- Generic Name
- Radiation blood/fluid warmer FDA UDI
- Device Name
- Fluido® Blood&Fluidwarmer (115V) FDA UDI
- Model / Reference
- 651115-US FDA UDI
- Description
- Fluido® Blood&Fluidwarmer (115V) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719867002790 FDA UDI
- 510(k) Number
- K251733 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- GMDN Term
- Radiation blood/fluid warmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Radiation blood/fluid warmer
Fluido® AirGuard System by The Surgical Company International B.V. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Surgical Company International B.V.
Sources (2)
- FDA UDI 992e3c5c-5e37-444e-86f3-672ed2f8b9e8 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 29, 2026