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B.pure 64409346B

by Fourstar Group Inc.

B.pure 64409346B is a Class I device made by Fourstar Group Inc., listed in FDA GUDID since 9 Jun 2026 (UDI-DI 00049696508346), 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 Number00049696508346 UDI-DI Date9 Jun 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  • Withdrawn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
B.pure
Generic name
Musculoskeletal hot/cold therapy pack, reusable
Model / reference
64409346B
Primary DI / UDI-DI
00049696508346
FDA product code
IME
GMDN term
Musculoskeletal hot/cold therapy pack, reusable
Device class
Class I
Regulation number
890.5700
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IME (Pack, Hot Or Cold, Reusable).

Other devices from Fourstar Group Inc.

See all devices from Fourstar Group Inc. →

Properties

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