CritiCool Mini 100-00023

GUDID 00850047646071

CritiCool® MINI, Cooling Control Unit (115V)

BELMONT INSTRUMENT CORPORATION

External circulating-fluid core temperature regulation system control unit, heating/cooling

• Primary Device ID: 00850047646071
• NIH Device Record Key: d83f879c-1d9c-425f-8b89-732dfa24cd75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CritiCool Mini
• Version Model Number: 100-00023
• Catalog Number: 100-00023
• Company DUNS: 078330362
• Company Name: BELMONT INSTRUMENT CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00850047646071 [Primary]
GS1	07290107581301 [Package]; Package: Outer Packaging [1 Units]; In Commercial Distribution

FDA Product Code

• DWJ: System, Thermal Regulating

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: 2025-11-24
• Device Publish Date: 2024-04-16

On-Brand Devices [CritiCool Mini]

• 07290107581301: CritiCool Mini Unit
• 00850047646071: CritiCool® MINI, Cooling Control Unit (115V)