Identity
- Trade Name
- SureFlow EUDAMEDFDA UDI
- Generic Name
- Medical gas flowmeter, Thorpe tube FDA UDI
- Device Name
- SureFlow EUDAMED2 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an accessory to the NewLife Intensity Concentrator or other oxygen source (not to exceed 50 psi) where there is a need to split the product flow to the concentrator to supply up to 5 different users. FDA UDI
- Model / Reference
- FM069-2 EUDAMEDFDA UDI
- Description
- 2 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an accessory to the NewLife Intensity Concentrator or other oxygen source (not to exceed 50 psi) where there is a need to split the product flow to the concentrator to supply up to 5 different users. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M766FM06920 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M766FM06920 EUDAMED
- FDA Product Code
- BXY FDA UDI
- EMDN Code
- Z120309 MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES EUDAMED
- GMDN Term
- Medical gas flowmeter, Thorpe tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.2350 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SureFlow by Caire Inc. — 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-M766FM06920 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CAIRE Inc.
- EUDAMED SRN
- US-MF-000013030
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 303eb767-7a5d-42f5-bd60-cae6a90da61c 61 fields · synced May 30, 2026
- FDA UDI ab8f7e1d-c090-41a7-84d5-e52146d174d5 33 fields · synced May 30, 2026