SunMed 4-0101-00
by SunMed
SunMed 4-0101-00 is an artificial airway cuff inflation tubing (FDA Class II; FDA product code BSK, Cuff, tracheal tube, inflatable) made by SunMed, cleared under FDA 510(k) K102674 on 22 Jul 2011 and listed in FDA GUDID since 17 Jul 2023 (UDI-DI 10889483002599), active 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 | Number10889483002599 | Date17 Jul 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102674 | Date22 Jul 2011 | StatusActive |
Official records
- AccessGUDID record 10889483002599
- FDA 510(k) database K102674
Across registries
- FDA 510(k) K102674 decided 22 Jul 2011 Active
- FDA GUDID UDI-DI 10889483002599 listed 17 Jul 2023 Listed
Timeline
- Cleared FDA 510(k) K102674
- Listed FDA GUDID 10889483002599
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SunMed
- Generic name
- Artificial airway cuff inflation tubing
- Model / Ref / Catalog
- 4-0101-00
- Primary DI / UDI-DI
- 10889483002599
- 510(k) Number
- FDA product code
- BSK
- GMDN term
- Artificial airway cuff inflation tubing
- Device class
- Class II
- Regulation number
- 868.5750
- GUDID distribution status
- In Commercial Distribution
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