FDA.reportPublic FDA data

Medline

Primary DI
10193489084917
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
CTBLOWER
Catalog number
CTBLOWER
Device description
COMFORTTEMP, BLOWER
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
10193489084917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348908491710193489084917

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-air core temperature regulation system control unit, heating/coolingAn electrically-powered device intended to be used as part of an external circulating-air core temperature regulation system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s core body temperature. The device includes a filter, an air heating and cooling mechanism and air pump. It is intended to be used by a healthcare professional in a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Keep Dry.
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
19332017004138CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
19332017004152CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
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00197998156410Solventum™ Bair Hugger™Solventum US LLCDWJ2026-01-30
00197998158469Solventum™ Bair Hugger™Solventum US LLCDWJ2026-01-30
00197998158490Solventum™ Bair Hugger™Solventum US LLCDWJ2026-01-30
00197998318184Solventum™ Bair Hugger™Solventum US LLCDWJ2026-01-30
00614801000062Medical Warming SystemsR.G. ENTERPRISES (U.S.A.), INC.DWJ2025-07-09
00614801000079Medical Warming SystemsR.G. ENTERPRISES (U.S.A.), INC.DWJ2025-07-09
00614801000086Medical Warming SystemsR.G. ENTERPRISES (U.S.A.), INC.DWJ2025-07-09
20197344129079MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
20197344129086MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07