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BSD-2000 Hyperthermia System BSD-2000B

by Pyrexar Medical, Inc. 2 variants

BSD-2000 Hyperthermia System BSD-2000B is a microwave hyperthermia system (FDA unclassified; FDA product code PAS, Rf/Microwave Hyperthermia System, Cancer Treatment) made by Pyrexar Medical, Inc., approved under a Humanitarian Device Exemption (HDE) H090002 and listed in FDA GUDID since 18 Jul 2023 (UDI-DI 00864445000403), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

HDE

Valid until

No date given

No validity date on record

FDA recalls

None found

in data synced 22 Oct 2026

Documents

HDE H090002

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00864445000403 UDI-DI Date18 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA HDE from GUDID NumberH090002 Date—HDE approvedStatusActive

Official records

Across registries

2 registries list this device

  • FDA HDE H090002 Active
  • FDA GUDID UDI-DI 00864445000403 listed 18 Jul 2023 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA HDE Active

Specification

GUDID

Trade name
BSD-2000 Hyperthermia System
Generic name
Microwave hyperthermia system
Model / reference
BSD-2000B
Primary DI / UDI-DI
00864445000403
PMA number
FDA product code
PAS
GMDN term
Microwave hyperthermia system
Device class
Unclassified
GUDID distribution status
In Commercial Distribution

Related devices

Category: Microwave hyperthermia system

Cleared under the same submission (H090002)

Other devices from Pyrexar Medical, Inc.

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)