MN0027
MN0027 is a xenon administration system (FDA Class II; FDA product code IYT, System, Rebreathing, Radionuclide) made by Medi Nuclear Corp., Inc., listed in FDA GUDID since 9 Nov 2020 (UDI-DI 00850022357169), 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 | Number00850022357169 | Date9 Nov 2020 | StatusListed |
Official records
- AccessGUDID record 00850022357169
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Xenon administration system, diagnostic x-ray/CT
- Model / reference
- MN0027
- Primary DI / UDI-DI
- 00850022357169
- 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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- VENTICIS II by Cis-Us, Inc.
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- XENON DELIVERY SYSTEM by Vital Signs, Inc.
- VENTI-SCAN II by Atomic Products Corp.
- BOLUS XENON CIRCUIT by Vital Signs, Inc.