FDA.reportPublic FDA data

Arctic Sun Stat Temperature Management System

Primary DI
00801741184314
Brand
Arctic Sun Stat Temperature Management System
Company
Medivance, Inc.
Model
72800
Catalog number
72800
Device description
Arctic Sun Stat Temperature Management System Fill Tube
Published
2024-08-26
Public version status
New
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
00801741184314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741184314008017411843148017411843140801741184314

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-fluid core temperature regulation system control unit, heating/coolingAn 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)823-5483lou.customerservice@bd.com

Regulatory Flags#

DUNS number
027183008
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00801741080159Arctic Sun® 500050000000L50000000L2016-09-11
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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