FDA.reportPublic FDA data

MEDLINE

Primary DI
20193489134787
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CTBLANKET555
Catalog number
CTBLANKET555
Device description
CTEMP, BLANKET, PEDIATRIC 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
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

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
20193489134787PackageGS110In Commercial Distribution
10193489134780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348913478720193489134787
1019348913478010193489134780

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.

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
false
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