Device
Solution Warmer, 230V for use with the Hush-Slush™ Model ORS-1075EU
Manufacturer
Microtek Medical LLC
Model: Surgical Slush - Hush-Slush Equipment Catalog: ORS-2038EU DI: 00748426146932 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-20 Current Version: 2026-05-28
Description
Solution Warmer, 230V for use with the Hush-Slush™ Model ORS-1075EU
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 478a1d58-7d66-44fc-a0f8-5dbbc30ac725
Distribution Status: In Commercial Distribution
DUNS Number: 106908437
Device Count: 1
DM Exempt: Yes
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: Yes
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00748426146932
Type: Primary
Issuing Agency: GS1
GMDN
Code: 33512
Name: Multi-purpose warming cabinet, mobile
Definition:
A 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.
FDA Product Codes
LHC
Warmer, Irrigation Solution
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit: Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value: 10
Item #1 - Storage Handling High - @attributes - Unit: Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value: 40
Item #1 - Storage Handling Type: Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit: Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value: 30
Item #2 - Storage Handling High - @attributes - Unit: Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value: 75
Item #2 - Storage Handling Type: Storage Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit: KiloPascal
Item #3 - Storage Handling Low - @attributes - Value: 70
Item #3 - Storage Handling High - @attributes - Unit: KiloPascal
Item #3 - Storage Handling High - @attributes - Value: 106
Item #3 - Storage Handling Type: Storage Environment Atmospheric Pressure