FDA.reportPublic FDA data

KoZee Warming Blanket

Primary DI
06951013002670
Brand
KoZee Warming Blanket
Company
Jiangmen Dacheng Medical Equipment Co., Ltd.
Model
M21001
Published
2023-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231596000IOB Temperature Management SystemIob Medical, Inc.2023-06-30DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26951013002674PackageGS140In Commercial Distribution
06951013002670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2695101300267426951013002674
06951013002670069510130026706951013002670

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-air whole-body heating/cooling system pad, single-useAn underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit (not included). The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
548017546
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
06951013002922FilteredFlo Warming BlanketFF-1452026-04-29
06951013002939FilteredFlo Warming BlanketFF-2432026-04-29
06951013002946FilteredFlo Warming BlanketFF-2442026-04-29
06951013002953FilteredFlo Warming BlanketFF-2462026-04-29
06951013002960FilteredFlo Warming BlanketFF-2472026-04-29
06951013002977FilteredFlo Warming BlanketFF-2482026-04-29
06951013002984FilteredFlo Warming BlanketFF-3442026-04-29
06951013002991FilteredFlo Warming BlanketFF-4422026-04-29
06951013003004FilteredFlo Warming BlanketFF-4432026-04-29
06951013001376IOBIOB-0242019-09-20
06951013001383IOBIOB-0252019-09-20
06951013001413IOBIOB-0282019-09-20
06951013001420IOBIOB-0292019-09-20
06951013001437IOBIOB-0302019-09-20
06951013001604IOBIOB-3012019-09-20
06951013001611IOBIOB-3022019-09-20
06951013001628IOBIOB-3032019-09-20
06951013001635IOBIOB-3042019-09-20
06951013001642IOBIOB-001S2019-09-20
06951013001659IOBIOB-002S2019-09-20

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