FDA.reportPublic FDA data

Medline-Microtek

Primary DI
00748426143153
Brand
Medline-Microtek
Company
Microtek Medical LLC
Model
Surgical Slush - Hush Slush Equipment
Catalog number
ESW7L-M
Device description
Hush Slush™ 2.0 Slush + Warmer System
Published
2025-10-14
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
00748426143153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00748426143153007484261431537484261431530748426143153

GMDN Terms#

Term, Definition table
TermDefinition
Ice maker/dispenserA mains electricity (AC-powered) device with the freezing capabilities to transform water from a liquid to a solid mass, producing non-contaminated ice. It will typically have a storage chamber that facilities automatic dispensing of the ice from a storage chamber when needed, or for manual collection. The ice produced can be used for a variety of purposes in healthcare settings, e.g., cooling and/or temporary preservation of blood, organs, tissues, in physiotherapy (used in ice bags or baths) or for cooling soft drinks. The storage bin can be either closed or open and the ice produced can be supplied as flakes, crushed, cubes or in other forms.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-18 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
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
00748426143139Medline-MicrotekMicrotek Medical LLCLHC2025-10-08
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