FDA.reportPublic FDA data

Kool-Kit

Primary DI
10613031839005
Brand
Kool-Kit
Company
Gentherm Medical, LLC
Model
900-USME
Catalog number
900-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
OTC
false
Sterile
false
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
20613031839002PrimaryGS10
10613031839005Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061303183900220613031839002
1061303183900510613031839005

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
Weight0.96Pound
Width11Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8009897373CSZ@genthermCSZ.com

Regulatory Flags#

DUNS number
004249462
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
20613031839200Kool-Kit 920-USME920-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
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