Hyperthermia Pump Accessory

GUDID 00896128002190

BELMONT INSTRUMENT CORPORATION

Extravascular-circulation hyperthermia system

• Primary Device ID: 00896128002190
• NIH Device Record Key: 5b7fe177-209c-45d4-a318-bdfbbaf6d0b4
• Commercial Distribution Discontinuation: 2023-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Hyperthermia Pump Accessory
• Version Model Number: 902-00015
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896128002190 [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2016-11-08

On-Brand Devices [Hyperthermia Pump Accessory]

• 00896128002190: 902-00015
• 00896128002176: 902-00011