Microfocus APA 1000 System

GUDID B0634100145

Focus Thermotherapy Device

Medifocus, Inc.

Microwave hyperthermia system

• Primary Device ID: B0634100145
• NIH Device Record Key: 07ee49f5-f266-4d38-930e-45ceed485ccb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microfocus APA 1000 System
• Version Model Number: Original
• Company DUNS: 828790159
• Company Name: Medifocus, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0634100145 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-18

Devices Manufactured by Medifocus, Inc.

• B0634100145 - Microfocus APA 1000 System: 2018-03-29Focus Thermotherapy Device
• B0634100145 - Microfocus APA 1000 System: 2018-03-29 Focus Thermotherapy Device
• B0638808060 - Prolieve: 2018-03-29 Prolieve Thermodilatation System
• B0638808260 - Prolieve: 2018-03-29 Prolieve Thermodilatation Single Use Kit