Arctic Sun® 5000 50000000

GUDID 00801741080142

Arctic Sun® 5000

Medivance, Inc.

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

• Primary Device ID: 00801741080142
• NIH Device Record Key: 6bfd9725-b0f6-4c53-a1f8-e39ae1b1c1da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arctic Sun® 5000
• Version Model Number: 50000000
• Catalog Number: 50000000
• Company DUNS: 027183008
• Company Name: Medivance, Inc.
• 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

Customer Support Contacts

• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741080142 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-11

On-Brand Devices [Arctic Sun® 5000]

• 00801741127755: Arctic Sun® 5000
• 00801741080159: Arctic Sun® 5000
• 00801741080142: Arctic Sun® 5000