Arctic Sun® Temperature Management System, Service Kit Model 5000

Basic Information

• Brand Name: Arctic Sun® Temperature Management System, Service Kit Model 5000
• Primary DI: 00801741080487
• Version / Model: 77100
• Catalog Number: 77100
• Company Name: Medivance, Inc.
• Labeler DUNS: 027183008
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-11
• Public Version: 3
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: ef7c78f6-1ed8-4cbf-8fc2-8d39dc3b2711

Device Description

Arctic Sun® Temperature Management System, Service Kit Model 5000

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWJ	System, thermal regulating	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36956	External circulating-fluid core temperature regulation system control unit, heating/cooling	An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s core body temperature. The device includes a heater and refrigeration unit, a pump, and typically a water reservoir; it may also be intended for patient temperature monitoring and typically includes alarms for cases of water temperatures beyond pre-set limits. It is intended to be used by a healthcare professional in a clinical setting (e.g., to achieve normothermia).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741080487	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]