Home GUDID 00850063139403 Neil Medical Group
Primary DI 00850063139403
Brand Neil Medical Group
Company Neil Medical Group
Model 2005-16FR
Device description PRE CONNECTED FOLEY TRAY WITH BAG 16FR
Published 2025-12-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 00850063139403 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 00850063139403 00850063139403 850063139403 0850063139403
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.
Regulatory Flags# DUNS number 122260045 Device count 1 Premarket exempt true Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 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