Xenotron 1
Xenotron 1 (N046A0) is a xenon administration system (FDA Class II; FDA product code IYT, System, rebreathing, radionuclide) made by Curium US LLC, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00369945000002), registry data as of 23 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 | Number00369945000002 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00369945000002
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Xenotron
- Generic name
- Xenon administration system, diagnostic x-ray/CT
- Model / Ref / Catalog
- 1, N046A0
- Primary DI / UDI-DI
- 00369945000002
- FDA product code
- IYT
- GMDN term
- Xenon administration system, diagnostic x-ray/CT
- Device class
- Class II
- Regulation number
- 892.1390
- GUDID distribution status
- In Commercial Distribution
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