Hyperthermia Pump Procedure Pack

GUDID 10896128002579

BELMONT INSTRUMENT CORPORATION

Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal

• Primary Device ID: 10896128002579
• NIH Device Record Key: 00ed03cf-fd42-4c5b-b32f-0df34aad7ed8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyperthermia Pump Procedure Pack
• Version Model Number: 902-00048
• 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	10896128002579 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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