CritiCool Mini 200-00336

GUDID 07290107581301

CritiCool Mini Unit

BELMONT INSTRUMENT CORPORATION

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

• Primary Device ID: 07290107581301
• NIH Device Record Key: d83f879c-1d9c-425f-8b89-732dfa24cd75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CritiCool Mini
• Version Model Number: 200-00336
• Catalog Number: 200-00336
• 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	07290107581301 [Primary]

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-24
• Device Publish Date: 2024-04-16

Devices Manufactured by BELMONT INSTRUMENT CORPORATION

• 07290107581301 - CritiCool Mini: 2024-04-24CritiCool Mini Unit
• 07290107581301 - CritiCool Mini: 2024-04-24 CritiCool Mini Unit
• 20896128002095 - buddy™ Disposable Set: 2024-04-23 6 X Box 24=144
• 17290012127332 - CureWrap™ Pediatric, 79-91cm (8 pack): 2024-03-27 Accessory for the CritiCool system.
• 00896128002077 - Hyperthermia Pump St In/Out Pt Line: 2024-02-19
• 00896128002169 - Hyperthermia Pump St In/Out Pt Line: 2024-02-19
• 00896128002176 - Hyperthermia Pump Accessory: 2024-02-19
• 00896128002190 - Hyperthermia Pump Accessory: 2024-02-19
• 00896128002237 - Hyperthermia Pump St In/Out Pt Line Kit w/ 3L Reservoir: 2024-02-19