Identity
- Trade Name
- CoSense ETCO Monitor FDA UDI
- Generic Name
- Carbon monoxide breath analyser FDA UDI
- Device Name
- A reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses. FDA UDI
- Model / Reference
- C20112 FDA UDI
- Description
- A reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858481006017 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carbon monoxide breath analyser
CoSense ETCO Monitor by Capnia, Inc. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253119 | Class II | Active |
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Manufacturer
- Manufacturer
- Capnia, Inc.
Sources (2)
- FDA UDI e8926e64-7d01-4f3b-9235-190f7d386781 35 fields · synced Jun 18, 2026
- FDA 510(k) K253119 1 fields · synced Jun 18, 2026