Identity
- Trade Name
- ClearMate FDA UDI
- Generic Name
- Oxygen/air breathing gas mixer, emergency FDA UDI
- Device Name
- Assy, ClearMate, DISS, US FDA UDI
- Model / Reference
- 128222 FDA UDI
- Description
- Assy, ClearMate, DISS, US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10807141000107 FDA UDI
- 510(k) Number
- DEN170044 FDA UDI
- FDA Product Code
- QFB FDA UDI
- GMDN Term
- Oxygen/air breathing gas mixer, emergency FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5480 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
No
FDA UDI
Category: Oxygen/air breathing gas mixer, emergency
Thornhill Research Inc's ClearMate is a portable, hand-held mechanical device designed to provide oxygen and mixing of air for mobile O2 administration. This compact unit offers a convenient and efficient solution for emergency situations or medical procedures requiring precise gas mixtures.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Thornhill Research Inc
Sources (1)
- FDA UDI b76f2017-a3e4-492d-aaca-0e80ab620b1c 35 fields · synced Jul 8, 2026