54-03-000
54-03-000 is an endotracheal tube cuff inflator (FDA Class II; FDA product code BSK, Cuff, Tracheal Tube, Inflatable) made by VBM Medizintechnik GmbH, cleared under FDA 510(k) K912723 on 20 Jul 1991 and listed in FDA GUDID since 17 Jan 2016 (UDI-DI 14250105600466), 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 | Number14250105600466 | Date17 Jan 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK912723 | Date20 Jul 1991 | StatusActive |
Official records
- AccessGUDID record 14250105600466
- FDA 510(k) database K912723
Across registries
- FDA 510(k) K912723 decided 20 Jul 1991 Active
- FDA GUDID UDI-DI 14250105600466 listed 17 Jan 2016 Listed
Timeline
- Cleared FDA 510(k) K912723
- Listed FDA GUDID 14250105600466
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Endotracheal tube cuff inflator
- Model / reference
- 54-03-000
- Primary DI / UDI-DI
- 14250105600466
- 510(k) Number
- FDA product code
- BSK
- GMDN term
- Endotracheal tube cuff inflator
- Device class
- Class II
- Regulation number
- 868.5750
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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