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Asp Global Primo Afoverlay-B-K

by Asp Global, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840216129269 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Asp Global Primo
Generic name
Alternating-pressure bed mattress overlay system
Model / reference
AFOVERLAY-B-K
Description
AIRFLOAT MATTRESS OVERLAY W/PUMP BUNDLE VERSION-B-K: CLOSED CIRCLES, OVAL HANDLES, 76"X32", PURPLE, UNINFLATED, W/PUMP, 600 LB WEIGHT LIMIT, 1SET/BG 6BG/CS
Primary DI / UDI-DI
00840216129269
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

Other devices from Asp Global, LLC

See all devices from Asp Global, LLC →

Properties

  • Premarket exempt
  • Lot / batch number

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No