FDA UDI
In Commercial Distribution
🇺🇸 United States
BSD-500 Hyperthermia System
DI: 00864445000434
·
Model: BSD-500
·
Pyrexar Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BSD-500 Hyperthermia System
- Primary DI
- 00864445000434
- Version / Model
- BSD-500
- Company Name
- Pyrexar Medical Inc.
- Labeler DUNS
- 079797900
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-18
- Public Version
- 1
- Public Version Date
- 2023-07-26
- Public Version Status
- New
- Public Device Record Key
- 3667631c-9e05-4a3e-ae17-ef299d1c7432
Device Description
The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malignant tumors by the external or interstitial application of electromagnetic energy and monitors the temperature of target and surrounding tissues by means of independent temperature sensors.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LOC | System, Rf/Microwave Hyperthermia, Cancer Treatment | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40783 | Microwave hyperthermia system | A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00864445000434 | GS1 | ||||
| Previous | 08644450004342 | GS1 |
Customer Contacts
- Phone
- +1(844)797-3927
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P820088 | 016 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity