Medline-Microtek ORS-1075HS

GUDID 00748426140695

Hush Slush Surgical Slush Machine

Microtek Medical LLC

Ice maker/dispenser

• Primary Device ID: 00748426140695
• NIH Device Record Key: c03a6479-5f5c-46c0-bfbc-8bf713707c50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medline-Microtek
• Version Model Number: Surgical Slush - Hush-Slush Equipment
• Catalog Number: ORS-1075HS
• Company DUNS: 106908437
• Company Name: Microtek Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00748426140695 [Primary]

FDA Product Code

• LHC: Warmer, Irrigation Solution

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-28
• Device Publish Date: 2025-04-18

On-Brand Devices [Medline-Microtek]

• 00748426141128: KNEE AND BODY STRAP, DISPOSABLE, NONWOVEN, TWO PIECE, 4" X 60"
• 00748426140503: Scope Pillow™ Warmer Drape, For use with ORS-2057 Series Fluid Warming System, 112 cm x 168 cm
• 00748426140466: Slush + Warmer Plate-Drape™, For use with ORS-1058 Hush-Slush™ System, 112 cm x 168 cm (44 i
• 00748426140442: Slush + Warmer Disc-Drape™, For use with ORS-1075HS Hush-Slush™ System, 132 cm x 168 cm (52
• 00748426140435: Slush + Warmer Disc-Drape™, For use with ORS-1075HS Hush-Slush™ System, 112 cm x 168 cm (44
• 00748426140428: Warmer Drape, For use with ORS-2000 Series Fluid Warming System, 132 cm x 168 cm (52 in x 66 in)
• 00748426140411: Warmer Drape, For use with ORS-2000 Series Fluid Warming System, 112 cm x 168 cm (44 in x 66 in)
• 00748426140404: Warmer Drape with Skirt, For use with ORS-2000 Series Fluid Warming System, 112 cm x 112 cm x 91
• 00748426140381: Warmer Drape, For use with ORS-2000 Series Fluid Warming System, 112 cm x 112 cm (44 in x 44 in)
• 00748426140374: Microtek Warmer Drape, For use with Microtek E Series and ORS-2000 Series Fluid Warming Systems,
• 00748426140350: Microtek Warmer Drape, For use with Microtek E Series and ORS-2000 Series Fluid Warming Systems,
• 00748426140336: Microtek Hush-Slush™ 2.0 Slush + Warmer Disc-Drape, 112 cm x 168 cm (44 in x 66 in)
• 00748426140312: Microtek Slush + Warmer Disc-Drape™, 112 cm x 168 cm (44 in x 66 in)
• 10748426140494: Scope Cradle™, For Use with O.R. Solutions Warming Systems
• 10748426140487: Scope Pillow™ Warmer Drape, For use with ORS-2057 Series Fluid Warming System, 112 cm x 168 cm
• 10748426140470: Slush + Warmer Plate-Drape™, For use with ORS-1058 Hush-Slush™ System, 132 cm x 168 cm (52 i
• 10748426140456: Slush + Warmer Plate-Drape™, For use with ORS-1058 Hush-Slush™ System, 112 cm x 168 cm (44 i
• 10748426140395: Warmer Drape with Skirt, For use with ORS-2000 Series Fluid Warming System, 112 cm x 112 cm x 91
• 10748426140364: Microtek Warmer Drape, For use with Microtek E Series and ORS-2000 Series Fluid Warming Systems,
• 10748426140340: Microtek Warmer Drape, For use with Microtek E Series and ORS-2000 Series Fluid Warming Systems,
• 10748426140326: Hush-Slush™ 2.0 Slush + Warmer Disc-Drape, For use with the Hush-Slush™ 2.0 (ESW7L) and Hush
• 00748426141104: Hush Slush Surgical Slush Machine
• 00748426140756: Irrigation Solution Warmer, 9.4 Liter
• 00748426140749: Irrigation Solution Warmer, 7.5 Liter
• 00748426140732: Irrigation Solution Warmer, 6.6 Liter
• 00748426140725: Irrigation Solution Warmer, 5.7 Liter
• 00748426140718: Irrigation Solution Warmer, 3.8 Liter
• 00748426140695: Hush Slush Surgical Slush Machine