Identity
- Trade Name
- BSD-2000 Hyperthermia System FDA UDI
- Generic Name
- Microwave hyperthermia system FDA UDI
- Device Name
- The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy. FDA UDI
- Model / Reference
- BSD-2000B FDA UDI
- Description
- The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864445000403 FDA UDI
- PMA Number
- H090002 FDA UDI
- FDA Product Code
- PAS FDA UDI
- GMDN Term
- Microwave hyperthermia system FDA UDI
Classification
- Device Class
- Unclassified FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microwave hyperthermia system
BSD-2000 Hyperthermia System by Pyrexar Medical, Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
H090002 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class Unclassified | Pending data |
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Manufacturer
- Manufacturer
- Pyrexar Medical, Inc.
Sources (1)
- FDA UDI dbdaa642-3cad-47d3-bc19-8eaaafb3fe05 36 fields · synced May 30, 2026