FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489134797
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CTBLANKET635
Catalog number
CTBLANKET635
Device description
CTEMP, BLANKET, FULL ACCESS UNDERBODY
Published
2024-06-25
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231211000Medline ComfortTemp Patient Warming SystemMedline Industries, LP2023-12-01DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489134794PackageGS110In Commercial Distribution
10193489134797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348913479420193489134794
1019348913479710193489134797

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-air core temperature regulation system pad, single-useAn underlay or overlay through which temperature-regulated air is circulated as part of an external circulating-air core temperature regulation system, intended to elevate and/or lower a patient’s 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260114141488ThermAffyx™Stihler Electronic GmbHDWJ2026-09-21
04260114141532ThermAffyx™Stihler Electronic GmbHDWJ2026-09-21
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
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