FDA.reportPublic FDA data

Arctic Sun® Temperature Management System, Temperature Cable Nellcor

Primary DI
00801741080296
Brand
Arctic Sun® Temperature Management System, Temperature Cable Nellcor
Company
Medivance, Inc.
Model
73502
Catalog number
73502
Device description
Arctic Sun® Temperature Management System, Temperature Cable Nellcor
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
00801741080296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741080296008017410802968017410802960801741080296

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).

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
Lot or batch
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0078755104171240675 Hot Pink Pad XL - with Arm ProtectorsXODUS MEDICAL, INC.DWJ2026-10-19
06951013004124KoZee Warming BlanketJiangmen Dacheng Medical Equipment Co., Ltd.DWJ2026-10-15
06950456323090NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323106NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323113NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323120NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323137NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323144NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323151NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323168NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323175NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323182NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323199NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323205NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323212NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323229NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323236NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323243NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323250NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323267NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323274NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323281NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323298NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323304NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323311NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323328NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323335NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323342NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323359NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323366NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30