Mallinckrodt 18775
by Covidien LP
Mallinckrodt 18775 is a Class II device made by Covidien LP, cleared under FDA 510(k) K090352 on 3 Apr 2009 and listed in FDA GUDID since 28 Aug 2015 (UDI-DI 50884522007601), 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 | Number50884522007601 | Date28 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090352 | Date3 Apr 2009 | StatusActive |
Official records
- AccessGUDID record 50884522007601
- FDA 510(k) database K090352
Across registries
- FDA 510(k) K090352 decided 3 Apr 2009 Active
- FDA GUDID UDI-DI 50884522007601 listed 28 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K090352
- Listed FDA GUDID 50884522007601
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mallinckrodt
- Generic name
- Basic endotracheal tube, single-use
- Model / reference
- 18775
- Primary DI / UDI-DI
- 50884522007601
- 510(k) Number
- FDA product code
- BTR
- GMDN term
- Basic endotracheal tube, single-use
- Device class
- Class II
- Regulation number
- 868.5730
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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