BUDDY LITE

GUDID 00896128002497

ASSY, BUDDY LITE BATTERY HOUSING AND HEATER UNIT

BELMONT INSTRUMENT CORPORATION

Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer

• Primary Device ID: 00896128002497
• NIH Device Record Key: 5c4ec322-1b14-4eb1-b987-67049b764321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BUDDY LITE
• Version Model Number: 403-00340
• 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: 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	00896128002497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090508

FDA Product Code

• BSB: Warmer, Blood, Non-Electromagnetic Radiation

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: 2022-03-22
• Device Publish Date: 2016-09-23

Devices Manufactured by BELMONT INSTRUMENT CORPORATION

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• 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