Identity
- Trade Name
- Fluido® Pressure Chamber EUDAMEDFluido® AirGuard System FDA UDI
- Generic Name
- Intravenous pressure infusor, automated FDA UDI
- Device Name
- Fluido® Pressure Chamber EUDAMEDFluido® Pressure Chambers FDA UDI
- Model / Reference
- 660300 EUDAMEDFDA UDI
- Description
- Fluido® Pressure Chambers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18719867001622 EUDAMEDFDA UDI
- Basic UDI-DI
- 8719867EMDNZ12030380PCK4 EUDAMED
- 510(k) Number
- K251733 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- EMDN Code
- Z12030380 INFUSION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Intravenous pressure infusor, automated 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
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Fluido® Pressure Chamber by The Surgical Company International B.V. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8719867EMDNZ12030380PCK4 | 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 2b2551ac-61d1-4b04-9c1c-ad27d16f5760 61 fields · synced Jun 18, 2026
- FDA UDI 430cdb14-4a3c-439a-82b6-2c64cf45a480 34 fields · synced May 30, 2026