Ncd-2025-8
Ncd-2025-8 is a Class II device made by Southmedic Incorporated, cleared under FDA 510(k) K131410 on 13 Jan 2014 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 10620974001642), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10620974001642 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131410 | Date13 Jan 2014 | StatusActive |
Official records
- AccessGUDID record 10620974001642
- FDA 510(k) database K131410
Across registries
- FDA 510(k) K131410 decided 13 Jan 2014 Active
- FDA GUDID UDI-DI 10620974001642 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K131410
- Listed FDA GUDID 10620974001642
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Nasal oxygen cannula, carbon-dioxide-sampling
- Model / Ref / Catalog
- NCD-2025-8
- Primary DI / UDI-DI
- 10620974001642
- 510(k) Number
- FDA product code
- CCK
- GMDN term
- Nasal oxygen cannula, carbon-dioxide-sampling
- Device class
- Class II
- Regulation number
- 868.1400
- GUDID distribution status
- Not in Commercial Distribution