BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNI

GUDID 20896128002446

ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, EUROPEAN, CHARGER

BELMONT INSTRUMENT CORPORATION

Conduction blood/fluid warmer

• Primary Device ID: 20896128002446
• NIH Device Record Key: abe922a4-af6e-4fdc-b13c-61b8f6f677c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNI
• Version Model Number: 905-00023
• 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	20896128002446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112639

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 LITE WITH AC, BATTERY HOUSING AND HEATER UNI]

• 70896128002441: ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, SWEDEN CHARGER
• 60896128002444: ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, AUSTRALIA CHARGER
• 50896128002447: ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, GERMANY, CHARGER
• 40896128002440: ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, SWITZERLAND, CHARGER
• 30896128002443: ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, UK, CHARGER
• 20896128002446: ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, EUROPEAN, CHARGER
• 10896128002449: ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, N. AMERICA , CHARGER