Device
Hush-Slush™ Slush System, 230V
Manufacturer
Microtek Medical LLC
Model: Surgical Slush - Hush-Slush Equipment Catalog: ORS-1075EU DI: 00748426146925 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
Hush-Slush™ Slush System, 230V
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: b5f0e811-d5a6-4841-85e0-3cc23957a0dc
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: 00748426146925
Type: Primary
Issuing Agency: GS1
GMDN
Code: 36756
Name: Ice maker/dispenser
Definition:
A 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.
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