Identity
- Trade Name
- Capnoxygen® FDA UDI
- Generic Name
- Breathing circuit gas-sampling/monitoring set FDA UDI
- Device Name
- Pediatric Capnoxygen Mask with 14ft oxygen tubing & Sampling Line Male 15ft FDA UDI
- Model / Reference
- CO2-04-SLM-14 FDA UDI
- Description
- Pediatric Capnoxygen Mask with 14ft oxygen tubing & Sampling Line Male 15ft FDA UDI
Identifiers
- Catalog Number
- CO2-04-SLM-14 FDA UDI
- Primary DI / UDI-DI
- 10620974001529 FDA UDI
- 510(k) Number
- K971229 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Breathing circuit gas-sampling/monitoring set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Capnoxygen® by Southmedic Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K971229 also covers:
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
- Southmedic Incorporated
Sources (1)
- FDA UDI 76d7403f-8f95-44a0-aad3-33d089ddd6e2 38 fields · synced May 30, 2026