FDA.reportPublic FDA data

Arctic Sun® 5000

Primary DI
00801741080159
Brand
Arctic Sun® 5000
Company
Medivance, Inc.
Model
50000000L
Catalog number
50000000L
Device description
Arctic Sun® 5000
Published
2016-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWJSystem, thermal regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741080159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741080159008017410801598017410801590801741080159

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid whole-body heating/cooling system control unitA mains electricity (AC-powered) device intended to be used as part of a circulating-fluid whole-body heating/cooling system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), for heating and alternatively cooling a patient’s whole-body (i.e., elevate or lower 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
027183008
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741184314Arctic Sun Stat Temperature Management System72800728002024-08-26
00801741080005Arctic Sun® Temperature Management System, ArcticGel™ Pads31700317002016-09-09
00801741080029Arctic Sun® Temperature Management System, ArcticGel™ Pads31702317022016-09-09
00801741080043Arctic Sun® Temperature Management System, ArcticGel™ Pads31703317032016-09-09
00801741080067Arctic Sun® Temperature Management System, ArcticGel™ Pads31705317052016-09-09
00801741080081Arctic Sun® Temperature Management System, ArcticGel™ Pads31707317072016-09-09
00801741080104Arctic Sun® Temperature Management System, ArcticGel™ Pads31709317092016-09-09
00801741080128Arctic Sun® Temperature Management System, ArcticGel™ Pads31801318012016-09-09
00801741132131Arctic Sun® Temperature Management System, ArcticGel™ Pads31802318022016-09-11
00801741161513Arctic Sun Stat60000000600000002020-07-23
00801741161520Arctic Sun Stat60000000L60000000L2020-07-23
00801741080142Arctic Sun® 500050000000500000002016-09-11
00801741080173Arctic Sun® Temperature Management System, Shunt Line70904709042016-09-11
00801741080180Arctic Sun® Temperature Management System, Drain Bag70905709052016-09-11
00801741080197Arctic Sun® Temperature Management System, Fill Tube71800718002016-09-11
00801741080203Arctic Sun® Temperature Management System, Drain Tube71900719002016-09-11
00801741080258Arctic Sun® Temperature Management System, Power Cord73300733002016-09-11
00801741080265Arctic Sun® Temperature Management System, Fluid Delivery Lines73407734072016-09-11
00801741080272Arctic Sun® Temperature Management System, Fluid Delivery Lines73408734082016-09-11
00801741080289Arctic Sun® Temperature Management System, Strap Kit, Fluid Delivery Line73490734902016-09-11

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Primary DI, Brand, Company table
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09332017002892CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
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