O2-Max 313-8007X
by Engineered Medical Systems, LLC
O2-Max 313-8007X is a Class II device made by Engineered Medical Systems, LLC, listed in FDA GUDID since 22 Jan 2016 (UDI-DI 00841470102197), 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 | Number00841470102197 | Date22 Jan 2016 | StatusListed |
Official records
- AccessGUDID record 00841470102197
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- O2-Max
- Generic name
- Respiratory oxygen therapy system
- Model / reference
- 313-8007X
- Primary DI / UDI-DI
- 00841470102197
- FDA product code
- BYE
- GMDN term
- Respiratory oxygen therapy system
- Device class
- Class II
- Regulation number
- 868.5965
- GUDID distribution status
- In Commercial Distribution
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