Home GUDID 00811727012340 Pointe Scientific, Inc.
Primary DI 00811727012340
Brand Pointe Scientific, Inc.
Company POINTE SCIENTIFIC, INC.
Model HI790-DET
Catalog number HI790-DET
Device description Pointe Scientific Detergent for cleaning Hitachi Analyzers. 1 x 1 Liter.
Published 2016-08-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00811727012340 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 00811727012340 00811727012340 811727012340 0811727012340
GMDN Terms# Term, Definition table Term Definition Medical device-decontamination agent A non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, surgical instruments/devices, and/or laboratory analysers/instruments for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 045623154 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00811727015709 Pointe Alkaline Phosphatase on the BS480 14-A7516-225 14-A7516-225 2020-05-28 00811727015723 Pointe Amylase on BS480 Analyzer 14-A7564-120 14-A7564-120 2020-05-28 00811727015730 Pointe AST on the BS480 Analyzer 14-A7561-375 14-A7561-375 2020-05-28 00811727015754 Pointe Calcium Arsenazo for BS480 14-C7529-360 14-C7529-360 2020-05-28 00811727015778 Pointe Cholesterol on BS480 14-C7510-480 14-C7510-480 2020-05-28 00811727015792 Pointe Carbon Dioxide on the BS480 14-C7502-160 14-C7502-160 2020-05-28 00811727015839 Pointe GGT on BS480 14-G7571-200 14-G7571-200 2020-05-28 00811727015846 Pointe Glucose Hexokinase for BS480 14-G7517-480 14-G7517-480 2020-05-28 00811727015860 Pointe autoHDL for the BS480 14-H7545-300 14-H7545-400 2020-05-28 00811727015877 Pointe Homocysteine for BS480 14-H7575-144 14-H7575-144 2020-05-28 00811727015884 Pointe Total Iron for the BS480 14-HI904-350 14-HI904-350 2020-05-28 00811727015693 Pointe Albumin on BS480 Analyzer 14-A7502-480 14-A7502-480 2020-05-28 00811727018632 Pointe Scientific CK-MB C7563-30 C7563-30 2021-02-28 00811727018649 Pointe Scientific CK-MB C7563-90 C7563-90 2021-02-28 00811727014139 Pointe G6PD Reagent G7583-180 G7583-180 2021-01-30 00811727015594 Pointe Lipoprotein (a) Control Set L7597-CTL L7597-CTL 2021-01-30 00811727015679 Pointe G6PD Controls G7583-CTL G7583-CTL 2021-01-30 00811727015815 Pointe CRP Reagent 14-C7568-480 14-C7568-480 2021-01-30 00811727015891 Pointe Lactate Reagent 14-L7596-380 14-L7596-380 2021-01-30 00811727015907 Pointe Lactate Dehydrogenase Reagent 14-L7572-200 14-L7572-200 2021-01-30
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