Home GUDID 00810185250479 Therapak
Primary DI 00810185250479
Brand Therapak
Company Therapak LLC
Model ACSK38534
Catalog number ACSK38534
Device description Hydrochloric Acid 24 Hour Urine Collection Kit (CS/24)
Published 2025-08-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LDW Fixative, Acid Containing
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LDW Fixative, Acid Containing Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810185250462 Primary GS1 0 00810185250479 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810185250462 00810185250462 810185250462 0810185250462 00810185250479 00810185250479 810185250479 0810185250479
GMDN Terms# Term, Definition table Term Definition 24-hour urine specimen container IVD, preservative A capped receptacle, typically 2 to 4 litres, containing one or multiple preservatives [e.g., boric acid (H3BO3), hydrochloric acid (HCl), sodium carbonate (Na2CO3), sulphuric acid (H2SO4)] and intended to be used for the collection, preservation, and transport of urine collected over a 24-hour period for analysis and/or other in vitro diagnostic investigation. This is a single-use device.
Regulatory Flags# DUNS number 791071165 Device count 24 DM exempt false Premarket exempt true 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# Other Devices Sharing Product Codes#