Home GUDID 00850006962075 HistoSonics
Primary DI 00850006962075
Brand HistoSonics
Company Histosonics, Inc.
Model HISFK2001
Device description Fluidics Disposable Kit
Published 2024-07-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name JRS Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JRS Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850006962075 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850006962075 00850006962075 850006962075 0850006962075
GMDN Terms# Term, Definition table Term Definition Combination water purification system An assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Humidity 10 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Storage Environment Temperature -15 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 028153599 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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