CureWrap™ Pediatric, 79-91cm (8 pack) 500-03531

GUDID 17290012127332

Accessory for the CritiCool system.

BELMONT INSTRUMENT CORPORATION

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

• Primary Device ID: 17290012127332
• NIH Device Record Key: 67a669fe-2317-4f71-9270-8b198c9cbb5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CureWrap™ Pediatric, 79-91cm (8 pack)
• Version Model Number: 500-03531
• Catalog Number: 500-03531
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07290012127335 [Package]; Contains: 77290012127334; Package: Single [1 Units]; In Commercial Distribution
GS1	17290012127332 [Primary]
GS1	77290012127334 [Package]; Package: Box [4 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: 6
• Public Version Date: 2024-03-27
• Device Publish Date: 2016-09-24

Devices Manufactured by BELMONT INSTRUMENT CORPORATION

• 00896128002336 - Slovene, Rapid Infuser, 230 V, 750ml/min: 2025-01-09 Fluid Warmer, 230V UNIT, 750ml/min
• 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): 2024-03-27Accessory for the CritiCool system.
• 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