FDA.reportPublic FDA data

Arctic Sun® Temperature Management System, ArcticGel™ Pads

Primary DI
00801741080067
Brand
Arctic Sun® Temperature Management System, ArcticGel™ Pads
Company
Medivance, Inc.
Model
31705
Catalog number
31705
Device description
Arctic Sun® Temperature Management System, ArcticGel™ Pads
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
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
10801741080064PackageGS11In Commercial Distribution
00801741080067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174108006410801741080064
00801741080067008017410800678017410800670801741080067

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-fluid core temperature regulation system pad, reusableAn underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
027183008
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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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08719867002646Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
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09332017002892CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
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