POM EZ-Lite 1003
POM EZ-Lite 1003 is a non-rebreathing oxygen face mask (FDA Class II; FDA product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) made by Stryker Corp., listed in FDA GUDID since 11 Jul 2018 (UDI-DI 10851438008086), 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 | Number10851438008086 | Date11 Jul 2018 | StatusListed |
Official records
- AccessGUDID record 10851438008086
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- POM EZ-Lite
- Generic name
- Non-rebreathing oxygen face mask
- Model / Ref / Catalog
- 1003
- Description
- Adult Procedural Oxygen Mask - Medium Concentration
- Primary DI / UDI-DI
- 10851438008086
- FDA product code
- CCK
- GMDN term
- Non-rebreathing oxygen face mask
- Device class
- Class II
- Regulation number
- 868.1400
- GUDID distribution status
- In Commercial Distribution
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