AG100s control unit
AG100s control unit (HSAG100S01) is an endotracheal tube intubation-management system (FDA Class II; FDA product code BSK, Cuff, Tracheal Tube, Inflatable) made by Hospitech Respiration Ltd, listed in FDA GUDID since 23 Mar 2019 (UDI-DI 07290015409100), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290015409100 | Date23 Mar 2019 | StatusListed |
Official records
- AccessGUDID record 07290015409100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Endotracheal tube intubation-management system
- Model / Ref / Catalog
- AG100s control unit, HSAG100S01
- Primary DI / UDI-DI
- 07290015409100
- FDA product code
- BSK
- GMDN term
- Endotracheal tube intubation-management system
- Device class
- Class II
- Regulation number
- 868.5750
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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