PremierPro 2485
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Overview
A comprehensive medical device directory listing for the PremierPro surgical/medical respirator, designed to provide a sterile and airtight seal while protecting both the user and patient from airborne particles.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00811220032326 | Date28 Apr 2020 | StatusListed |
Official records
- AccessGUDID record 00811220032326
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- PremierPro
- Generic name
- Surgical/medical respirator, non-antimicrobial, single-use
- Model / reference
- 2485
- Primary DI / UDI-DI
- 00811220032326
- FDA product code
- MSH
- GMDN term
- Surgical/medical respirator, non-antimicrobial, single-use
- Device class
- Class II
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
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