Skip to content

Primo SC101P-K

by Asp Global, LLC

Primo SC101P-K is a Class I device made by Asp Global, LLC, listed in FDA GUDID since 21 May 2026 (UDI-DI 00840216129245), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840216129245 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  • Withdrawn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
Primo
Generic name
Air-filled chair cushion
Model / reference
SC101P-K
Primary DI / UDI-DI
00840216129245
FDA product code
FMP
GMDN term
Air-filled chair cushion
Device class
Class I
Regulation number
880.6450
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FMP (Protector, Skin Pressure).

Other devices from Asp Global, LLC

See all devices from Asp Global, LLC →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)