BUDDY DISPOSABLE SET

GUDID 00896128002091

BUDDY DISPOSABLE SET, EACH POUCH

BELMONT INSTRUMENT CORPORATION

Conduction blood/fluid warmer set

• Primary Device ID: 00896128002091
• NIH Device Record Key: dcabf1e9-2a19-4014-9cf4-8ea302622c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BUDDY DISPOSABLE SET
• Version Model Number: 905-00010P
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896128002091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031478

FDA Product Code

• BSB: Warmer, Blood, Non-Electromagnetic Radiation

Sterilization

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

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

On-Brand Devices [BUDDY DISPOSABLE SET]

• 10896128002098: BUDDY DISPOSABLE SET, 24 SETS PER BOX
• 00896128002091: BUDDY DISPOSABLE SET, EACH POUCH