Identity
- Trade Name
- SureFlow FDA UDI
- Generic Name
- Medical gas flowmeter, Thorpe tube FDA UDI
- Device Name
- 1 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
- FM069-1 FDA UDI
- Description
- 1 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
- M766FM06910 FDA UDI
- FDA Product Code
- BXY FDA UDI
- GMDN Term
- Medical gas flowmeter, Thorpe tube FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2350 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical gas flowmeter, Thorpe tube
SureFlow by Caire Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Caire Inc.
Sources (2)
- FDA UDI 082758f4-a19b-4f49-9a19-a88dc0fbad61 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026