Home GUDID 20816490021104 Healgen
Primary DI 20816490021104
Brand Healgen
Company Healgen Scientific Limited Liability Company
Model HURS-1T
Catalog number HURS-1T
Device description 1 parameter Urine Strip
Published 2017-05-09
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 true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10816490021107 Package GS1 100 In Commercial Distribution 20816490021104 Package GS1 100 In Commercial Distribution 00816490021100 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 10816490021107 10816490021107 20816490021104 20816490021104 00816490021100 00816490021100 816490021100 0816490021100
GMDN Terms# Term, Definition table Term Definition Urine ketone IVD, kit, colorimetric dipstick, rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for ketones within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 031802328 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#