FDA.reportPublic FDA data

Kool-Kit

Primary DI
20613031839200
Brand
Kool-Kit
Company
Gentherm Medical, LLC
Model
920-USME
Catalog number
920-USME
Device description
Thermal Regulation Pad
Published
2024-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
20613031839200PrimaryGS10
10613031839203Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061303183920020613031839200
1061303183920310613031839203

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-fluid core temperature regulation system pad, single-useAn 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, full-/partial-body). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth3Inch
Length14.25Inch
Weight0.62Pound
Width11Inch

Contacts#

Phone, Email table
PhoneEmail
8009897373CSZ@genthermCSZ.com

Regulatory Flags#

DUNS number
004249462
Device count
5
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10613031871074Blanketrol233871072024-06-25
20613031838739Maxi-Therm Lite 873-USME873-USME2024-05-13
20613031838746Maxi-Therm Lite 874-USME874-USME2024-05-13
20613031838760Maxi-Therm Lite 876-USME876-USME2024-05-13
20613031839002Kool-Kit 900-USME900-USME2024-05-13
20613031839309Kool-Kit 930-USME930-USME2024-05-13
20613031839507Kool-Kit 950-USME950-USME2024-05-13
10613031873078Blanketrol2332332024-05-13
10613031838732Maxi-Therm Lite 873-USME873-USME2024-05-13
10613031838749Maxi-Therm Lite 874-USME874-USME2024-05-13
10613031838763Maxi-Therm Lite 876-USME876-USME2024-05-13
10613031839005Kool-Kit 900-USME900-USME2024-05-13
10613031839203Kool-Kit 920-USME920-USME2024-05-13
10613031839302Kool-Kit 930-USME930-USME2024-05-13
10613031839500Kool-Kit 950-USME950-USME2024-05-13
20613031812432FilteredFlo® PACU Adult Blanket243812432022-08-22
20613031812449FilteredFlo® Pediatric Blanket244812442022-08-22
20613031832430FilteredFlo® PACU Adult Blanket243832432017-08-30
20613031832461FilteredFlo® Neonate/Pediatric Blanket246832462022-08-22
20613031842439FilteredFlo® PACU Adult Blanket243842432022-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09332017002991CocoonCARE ESSENTIALS PTY LTDDWJ2026-04-29
09332017004131CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
09332017004155CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
10197344129072MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
10197344129089MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
08719867002639Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
08719867002653Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
09332017002861CocoonCARE ESSENTIALS PTY LTDDWJ2024-12-20
09332017003257CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003295CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003301CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003318CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003325CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003332CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003349CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
08719867002646Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
08719867002660Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
10193489134773MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134780MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134797MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012770MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012817MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012831MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344013401MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012794MedlineMEDLINE INDUSTRIES, INC.DWJ2024-04-30
09332017002885CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017002892CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017000645CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017002168CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017001178CocoonCARE ESSENTIALS PTY LTDDWJ2021-06-01