Arctic Sun Stat Temperature Management System 72800

GUDID 00801741184314

Arctic Sun Stat Temperature Management System Fill Tube

Medivance, Inc.

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

• Primary Device ID: 00801741184314
• NIH Device Record Key: e98847bb-dfa4-4fe3-a2c1-9730784f525b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arctic Sun Stat Temperature Management System
• Version Model Number: 72800
• Catalog Number: 72800
• 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: true
• Serial Number: false
• 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(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com
• Phone: +1(844)823-5483
• Email: lou.customerservice@bd.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741184314 [Primary]

FDA Product Code

• DWJ: System, thermal regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-03
• Device Publish Date: 2024-08-26

Devices Manufactured by Medivance, Inc.

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• 00801741161520 - Arctic Sun Stat: 2020-07-31 ARCTIC SUN 6000 115V B PWR LNR
• 10801741080002 - Arctic Sun® Temperature Management System, ArcticGel™ Pads: 2018-03-29 Arctic Sun® Temperature Management System, ArcticGel™ Pads
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• 10801741080040 - Arctic Sun® Temperature Management System, ArcticGel™ Pads: 2018-03-29 Arctic Sun® Temperature Management System, ArcticGel™ Pads
• 10801741080064 - Arctic Sun® Temperature Management System, ArcticGel™ Pads: 2018-03-29 Arctic Sun® Temperature Management System, ArcticGel™ Pads
• 10801741080088 - Arctic Sun® Temperature Management System, ArcticGel™ Pads: 2018-03-29 Arctic Sun® Temperature Management System, ArcticGel™ Pads