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Tub Pad BP01

by Primo Inc

Tub Pad BP01 is a Class I device made by Primo Inc, listed in FDA GUDID since 20 Feb 2019 (UDI-DI 00810006681345), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810006681345 UDI-DI Date20 Feb 2019ListedStatusListed 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  • Withdrawn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
Tub Pad
Generic name
Freestanding patient positioner, reusable
Model / Ref / Catalog
BP01
Primary DI / UDI-DI
00810006681345
FDA product code
FMP
GMDN term
Freestanding patient positioner, reusable
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 Primo Inc

See all devices from Primo Inc →

Properties

  • Premarket exempt
  • Lot / batch number
Other properties (13, all answered No)