Primo Afoverlay-a
Primo Afoverlay-a is a Class I device made by Asp Global, LLC, listed in FDA GUDID since 21 Mar 2023 (UDI-DI 00840216122659), 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 | Number00840216122659 | Date21 Mar 2023 | StatusListed |
Official records
- AccessGUDID record 00840216122659
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Primo
- Generic name
- Alternating-pressure bed mattress overlay system
- Model / reference
- AFOVERLAY-A
- Description
- AIRFLOAT MATTRESS OVERLAY W/PUMP BUNDLE VERSION-A: OPEN CIRCLES, CIRCULAR HANDLES, 76"X32", PURPLE, UNINFLATED, W/PUMP, 600 LB WEIGHT LIMIT, 1SET/BG 6BG/CS
- Primary DI / UDI-DI
- 00840216122659
- FDA product code
- FMP
- GMDN term
- Alternating-pressure bed mattress overlay system
- Device class
- Class I
- Regulation number
- 880.6450
- GUDID distribution status
- In Commercial Distribution
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