Home GUDID 10192253051612 Dover
Primary DI 10192253051612
Brand Dover
Company Cardinal Health 200, LLC
Model 5204
Catalog number 5204
Device description Urine Collection Kit
Published 2024-08-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Sterile true
Single use true Product Codes# Code, Name table Code Name FCN Urinary drainage collection kit, for indwelling catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50192253051610 Package GS1 48 In Commercial Distribution 10192253051612 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 50192253051610 50192253051610 10192253051612 10192253051612
GMDN Terms# Term, Definition table Term Definition Midstream urine specimen container IVD A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 4.5 Fluid Ounce
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 961027315 Device count 1 Premarket exempt true Kit true Combination product true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850067913054 Fig Leaf® HR PHARMACEUTICALS INC. FCN 2026-10-15 00850067913061 Fig Leaf® HR PHARMACEUTICALS INC. FCN 2026-10-15 00850067913078 Fig Leaf® HR PHARMACEUTICALS INC. FCN 2026-10-15 00850067913030 Fig Leaf® HR PHARMACEUTICALS INC. FCN 2026-10-14 00850067913047 Fig Leaf® HR PHARMACEUTICALS INC. FCN 2026-10-14 00840117351684 Universal Catheterization Procedure Trays with 2000 mL Anti-Reflux Drainage Bag Dynarex Corporation FCN 2026-07-31 00850063139403 Neil Medical Group Neil Medical Group FCN 2025-12-08 00850063139410 Neil Medical Group Neil Medical Group FCN 2025-12-08 00850063139427 Neil Medical Group Neil Medical Group FCN 2025-12-08 10192253051629 Dover Cardinal Health 200, LLC FCN 2025-11-07 00661392002388 LSL HEALTHCARE LSL Industries, LLC FCN 2025-10-30 00661392025646 LSL HEALTHCARE LSL Industries, LLC FCN 2025-10-30 10840330701751 ProCure Twin Med, LLC FCN 2025-05-31 10840330701768 ProCure Twin Med, LLC FCN 2025-05-31 10840330701775 ProCure Twin Med, LLC FCN 2025-05-31 10840330701782 ProCure Twin Med, LLC FCN 2025-05-31 30840330701755 ProCure Twin Med, LLC FCN 2025-05-31 30840330701762 ProCure Twin Med, LLC FCN 2025-05-31 30840330701779 ProCure Twin Med, LLC FCN 2025-05-31 30840330701786 ProCure Twin Med, LLC FCN 2025-05-31 00850058254791 TruCath HR PHARMACEUTICALS INC. FCN 2025-01-16 10192253027686 Dover Cardinal Health 200, LLC FCN 2024-10-14 50192253027684 Dover Cardinal Health 200, LLC FCN 2024-10-14 10192253065480 Dover Cardinal Health 200, LLC FCN 2024-09-03 10192253065497 Dover Cardinal Health 200, LLC FCN 2024-09-03 10192253065619 Dover Cardinal Health 200, LLC FCN 2024-09-03 10192253065626 Dover Cardinal Health 200, LLC FCN 2024-09-03 50192253065488 Dover Cardinal Health 200, LLC FCN 2024-09-03 50192253065495 Dover Cardinal Health 200, LLC FCN 2024-09-03 50192253065617 Dover Cardinal Health 200, LLC FCN 2024-09-03