Identity
- Trade Name
- ToxCO FDA UDI
- Generic Name
- Carbon monoxide breath analyser FDA UDI
- Device Name
- The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Monoxide (CO) poisoning and calculation of the Carboxyhaemoglobin (COHb) level. The ToxCO Breath Carbon Monoxide Monitor can be used by healthcare professionals in medical institutions, emergency medical services where Carbon Monoxide exposure is suspected for paediatric, adult, and unconscious patients. FDA UDI
- Model / Reference
- ToxCO FDA UDI
- Description
- The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Monoxide (CO) poisoning and calculation of the Carboxyhaemoglobin (COHb) level. The ToxCO Breath Carbon Monoxide Monitor can be used by healthcare professionals in medical institutions, emergency medical services where Carbon Monoxide exposure is suspected for paediatric, adult, and unconscious patients. FDA UDI
Identifiers
- Catalog Number
- TOXCO-USA FDA UDI
- Primary DI / UDI-DI
- 05060246860030 FDA UDI
- 510(k) Number
- K173238 FDA UDI
- FDA Product Code
- CCJ FDA UDI
- GMDN Term
- Carbon monoxide breath analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1430 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Carbon monoxide breath analyser
ToxCO by Bedfont Scientific Limited — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Bedfont Scientific Limited
Sources (1)
- FDA UDI a1438018-131d-4061-b72e-8658e5bbbb84 35 fields · synced Jun 1, 2026