FDA.reportPublic FDA data

Kozee

Primary DI
08973920006518
Brand
Kozee
Company
SOURCEMARK, LLC.
Model
M21002
Device description
Lower Body Warming Blanket Intraoperative
Published
2020-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
18973920006768PackageGS140In Commercial Distribution
08973920006518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1897392000676818973920006768
08973920006518089739200065188973920006518

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-air whole-body heating system control unitA mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heating a patient’s whole-body (i.e., elevate core body temperature to achieve normothermia). The device includes a filter, an air heater and air pump. It is intended to be used by a healthcare professional in a clinical setting.

Regulatory Flags#

DUNS number
121225812
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813799000003SourceMark M09062020-07-07
00813799000034SourceMark M09082020-07-07
00813799000065SourceMark M09102020-07-07
00813799000096SourceMark M0912 2020-07-07
00813799000126SourceMark M09142020-07-07
00813799007354SourceMark M09062020-11-06
00813799007385SourceMark M09082020-11-06
00813799007415SourceMark M09102020-11-06
00813799007446SourceMark M09122020-11-06
00813799007477SourceMark M09142020-11-06
00897392001322SourceMark M09142016-08-26
00897392001339SourceMark M09102016-08-26
00897392001346SourceMark M09062016-08-26
00813799005084SourceMark M1205 2020-07-09
00813799002748SourceMark CV3WF2022-02-24
00813799002861SourceMark CV1002022-02-24
00813799002878SourceMark CVST12022-02-24
08973920006501KozeeM210012020-01-27
08973920006525KozeeM210032020-01-27
08973920006532KozeeM210042020-01-27

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