Home GUDID 50192253065488 Dover
Primary DI 50192253065488
Brand Dover
Company Cardinal Health 200, LLC
Model P4P16XCSDK2
Catalog number P4P16XCSDK2
Device description 100 percent Silicone Silver Hydrogel Coated Urine Meter Foley Tray with Coude tip
Published 2024-09-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 50192253065488 Package GS1 10 In Commercial Distribution 10192253065480 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 50192253065488 50192253065488 10192253065480 10192253065480
GMDN Terms# Term, Definition table Term Definition Indwelling urethral catheterization kit, adult A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.
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 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 50192253065495 Dover Cardinal Health 200, LLC FCN 2024-09-03 50192253065617 Dover Cardinal Health 200, LLC FCN 2024-09-03 50192253065624 Dover Cardinal Health 200, LLC FCN 2024-09-03 10192253051612 Dover Cardinal Health 200, LLC FCN 2024-08-08 50192253051610 Dover Cardinal Health 200, LLC FCN 2024-08-08 10850053289085 SURGYCO Surgyco LLC FCN 2023-12-15 10850053289092 SURGYCO Surgyco LLC FCN 2023-12-15 10850053289108 SURGYCO Surgyco LLC FCN 2023-12-15 00850053289088 SURGYCO Surgyco LLC FCN 2023-12-15