Fenem 301-5534
by Engineered Medical Systems, LLC
Fenem 301-5534 is a Class II device made by Engineered Medical Systems, LLC, listed in FDA GUDID since 12 Dec 2023 (UDI-DI 00841470108373), 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 | Number00841470108373 | Date12 Dec 2023 | StatusListed |
Official records
- AccessGUDID record 00841470108373
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Fenem
- Generic name
- Exhaled-gas oesophageal intubation detector
- Model / reference
- 301-5534
- Primary DI / UDI-DI
- 00841470108373
- FDA product code
- BTM
- GMDN term
- Exhaled-gas oesophageal intubation detector
- Device class
- Class II
- Regulation number
- 868.5915
- GUDID distribution status
- In Commercial Distribution
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