FDA.reportPublic FDA data

Medline-Microtek

Primary DI
00748426143139
Brand
Medline-Microtek
Company
Microtek Medical LLC
Model
Fluid Warming - CoreTemp Equipment
Catalog number
CTW5L-M
Device description
CoreTemp™ Fluid Warmer
Published
2025-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LHCWarmer, Irrigation Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHCWarmer, Irrigation SolutionPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00748426143139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00748426143139007484261431397484261431390748426143139

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose warming cabinet, mobileA mains electricity (AC-powered) mobile device designed to warm various items and products prior to use, e.g., bags of irrigation or intravenous (IV) solutions, blankets or clothing to cover or put onto a patient, or clothing for the operating room (OR) personnel to adorn. It typically consists of a heat insulated enclosure with a sealing door, shelves, heating element(s), a thermostat and operating controls. This is a freestanding cabinet equipped with wheels that is designed to be wheeled (moved) from one location to another within a building complex. It may also be used in a laboratory.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
106908437
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00748426146802Medline-MicrotekFluid Warming - Warmer EquipmentEFW5L2026-05-20
00748426146925Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-1075EU2026-05-20
00748426146932Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-2038EU2026-05-20
00748426262076AQUABLATION THERAPY®Patient DrapesDR39002026-04-06
00748426264483Medline-MicrotekPatient Drapes5960UK2026-03-16
00748426264490Medline-MicrotekEquipment Drapes8033651EU2026-03-16
00748426264506Medline-MicrotekEquipment Drapes49652026-03-16
20748426264487Medline-MicrotekPatient Drapes5960UK2026-03-16
20748426264494Medline-MicrotekEquipment Drapes8033651EU2026-03-16
10748426264503Medline-MicrotekEquipment Drapes49652026-03-16
00748426264315Medline-MicrotekPatient Drapes59602026-02-11
00748426261543NA33206633202026-02-26
10748426261540NA33206633202026-02-26
10748426144294Medline-MicrotekEquipment Drapes5096NS2026-02-18
10748426144560Medline-MicrotekEquipment Drapes15427-002026-02-18
10748426144584Medline-MicrotekEquipment Drapes2904N2026-02-18
10748426144591Medline-MicrotekEquipment Drapes4604N2026-02-18
10748426144607Medline-MicrotekEquipment Drapes4650N2026-02-18
10748426144614Medline-MicrotekEquipment Drapes4954N2026-02-18
10748426144621Medline-MicrotekEquipment Drapes5900N2026-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426146802Medline-MicrotekMicrotek Medical LLCLHC2026-05-20
00748426146925Medline-MicrotekMicrotek Medical LLCLHC2026-05-20
00748426146932Medline-MicrotekMicrotek Medical LLCLHC2026-05-20
00841027100485Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027100508Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101000Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101109Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101307Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101314Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102793Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102809Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102816Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102823Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027103059Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00748426137855Medline-MicrotekMicrotek Medical LLCLHC2025-11-05
00748426143146Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143153Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143160Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143177Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143184Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143191Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143306Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143313Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143320Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426140695Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140718Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140725Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140732Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140749Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140756Medline-MicrotekMicrotek Medical LLCLHC2025-04-18