Hyperthermia Pump St In/Out Pt Line

GUDID 00896128002077

BELMONT INSTRUMENT CORPORATION

Extravascular-circulation hyperthermia system applicator, intracorporeal

• Primary Device ID: 00896128002077
• NIH Device Record Key: e3f01d5d-9ec1-413b-a317-1e992bc3418b
• Commercial Distribution Discontinuation: 2023-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Hyperthermia Pump St In/Out Pt Line
• Version Model Number: 902-00010P
• Company DUNS: 078330362
• Company Name: BELMONT INSTRUMENT CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896128002077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152208

FDA Product Code

• LGZ: Warmer, Thermal, Infusion Fluid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2016-09-23

On-Brand Devices [Hyperthermia Pump St In/Out Pt Line]

• 00896128002169: 902-00039P
• 00896128002077: 902-00010P