Home GUDID 10851616002035 SteriGear
Primary DI 10851616002035
Brand SteriGear
Company Sterigear, LLC
Model UE4001-00
Device description Fig Leaf Leg Bag 10272
Published 2020-11-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
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 10851616002035 Package GS1 48 In Commercial Distribution 00851616002038 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 10851616002035 10851616002035 00851616002038 00851616002038 851616002038 0851616002038
GMDN Terms# Term, Definition table Term Definition Wearable adult urine collection bag, open-ended A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at room temperature
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 809509297 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit false 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 true Sterilization required before use true 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 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 50192253027684 Dover Cardinal Health 200, LLC FCN 2024-10-14 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 50192253051610 Dover Cardinal Health 200, LLC FCN 2024-08-08 00850053289088 SURGYCO Surgyco LLC FCN 2023-12-15 00850053289095 SURGYCO Surgyco LLC FCN 2023-12-15 00850053289101 SURGYCO Surgyco LLC FCN 2023-12-15 10350770003389 NEOMED* Avanos Medical, Inc. FCN 2021-08-27 10350770003396 NEOMED* Avanos Medical, Inc. FCN 2021-08-27 10350770003402 NEOMED* Avanos Medical, Inc. FCN 2021-08-27 10350770003419 NEOMED* Avanos Medical, Inc. FCN 2021-08-27 10350770003426 NEOMED* Avanos Medical, Inc. FCN 2021-08-27 10851616002462 SteriGear Sterigear, LLC FCN 2021-05-11 10851616002561 SteriGear Sterigear, LLC FCN 2021-05-11 10851616002585 SteriGear Sterigear, LLC FCN 2021-05-11 50885380176706 Dover Cardinal Health, Inc. FCN 2021-03-17 50885380176713 Dover Cardinal Health, Inc. FCN 2021-03-17 50885380176720 Dover Cardinal Health, Inc. FCN 2021-03-17 50885380176737 Dover Cardinal Health, Inc. FCN 2021-03-17 10851616002028 SteriGear Sterigear, LLC FCN 2020-11-17 10851616002004 SteriGear Sterigear, LLC FCN 2020-11-13
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