Prolieve

GUDID B0638808260

Prolieve Thermodilatation Single Use Kit

Medifocus, Inc.

Microwave hyperthermia system

• Primary Device ID: B0638808260
• NIH Device Record Key: eefe2379-a9c1-4e0a-b0b2-8d7bccf3dd57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prolieve
• Version Model Number: Coude Tip Catheter
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0638808260 [Primary]

Sterilization

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

Device Entry Metadata

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

On-Brand Devices [Prolieve]

• B0638808260: Prolieve Thermodilatation Single Use Kit
• B0638808060: Prolieve Thermodilatation System