AccessGUDID - DEVICE: Medline-Microtek (00748426140695)

GUDID

Device Identifier (DI) Information

Brand Name: Medline-Microtek
Version or Model: Surgical Slush - Hush-Slush Equipment
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ORS-1075HS
Company Name: Microtek Medical LLC

Primary DI Number: 00748426140695
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106908437 *Terms of Use

Device Description: Hush Slush Surgical Slush Machine

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36756	Ice maker/dispenser	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHC	Warmer, Irrigation Solution

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c03a6479-5f5c-46c0-bfbc-8bf713707c50
Public Version Date: April 28, 2025
Public Version Number: 1
DI Record Publish Date: April 18, 2025