Identity
- Trade Name
- Resp-O2 Mini Oxygen Regulator, CGA 870 Style FDA UDI
- Generic Name
- Non-fixed medical gas cylinder regulator FDA UDI
- Device Name
- resp-O2 Mini Oxygen Regulator, CGA 870 Style, Barb Outlet, Brass-Sleeved, Flow Range: 0-8 LPM FDA UDI
- Model / Reference
- 36355 FDA UDI
- Description
- resp-O2 Mini Oxygen Regulator, CGA 870 Style, Barb Outlet, Brass-Sleeved, Flow Range: 0-8 LPM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117310025 FDA UDI
- FDA Product Code
- CAN FDA UDI
- GMDN Term
- Non-fixed medical gas cylinder regulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2700 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-fixed medical gas cylinder regulator
Resp-O2 Mini Oxygen Regulator, CGA 870 Style by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI f2341664-8a57-4e68-be51-0c673bac6df7 33 fields · synced Jun 1, 2026