buddy 2 SYSTEM

GUDID 10896128002821

BUDDY 2 SYSTEM, DUTCH

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 Conduction blood/fluid warmer

• Primary Device ID: 10896128002821
• NIH Device Record Key: 27302583-a370-4a64-b9d4-d999bb4d7a45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: buddy 2 SYSTEM
• Version Model Number: 905-00037-D
• 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	10896128002821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK150301

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [buddy 2 SYSTEM]

• 20896128002828: BUDDY 2 SYSTEM, FRENCH
• 10896128002821: BUDDY 2 SYSTEM, DUTCH
• 00896128002855: BUDDY 2 SYSTEM,GERMANY
• 00896128002848: BUDDY 2 SYSTEM, UK
• 00896128002831: BUDDY 2 SYSTEM, ENGLISH