Home GUDID 00810040135163
Safe N Simple
Primary DI 00810040135163
Brand Safe N Simple
Company SAFE N' SIMPLE LLC
Model SNS7501134-NC
Catalog number SNS7501134-NC
Device description 9" Urostomy 2-Piece Pouch Beige 50 mm 2" Flange with Valve and Belt Tabs
Published 2024-11-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true
Product Codes# Code, Name table Code Name EXG Bag, Urine Collecting, Ureterostomy
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EXG Bag, Urine Collecting, Ureterostomy Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810040135170 Primary GS1 0 00810040135187 Primary GS1 0 00810040135163 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 00810040135170 00810040135170 810040135170 0810040135170 00810040135187 00810040135187 810040135187 0810040135187 00810040135163 00810040135163 810040135163 0810040135163
GMDN Terms# Term, Definition table Term Definition Multiple-piece urostomy bag, open-ended A plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/changed. This is a single-use device.
Regulatory Flags# DUNS number 807812412 Device count 80 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 06974795055948 MDK-MEDICAL Henan Maidingkang Medical Technology Co., Ltd. EXG 2025-04-23 06974795058116 MDK-MEDICAL Henan Maidingkang Medical Technology Co., Ltd. EXG 2025-04-23 06974795059199 MDK-MEDICAL Henan Maidingkang Medical Technology Co., Ltd. EXG 2025-04-23 00810040135170 Safe N Simple SAFE N' SIMPLE LLC EXG 2024-11-08 00810040135187 Safe N Simple SAFE N' SIMPLE LLC EXG 2024-11-08 00810040135248 Safe N Simple SAFE N' SIMPLE LLC EXG 2024-11-08 00810040135255 Safe N Simple SAFE N' SIMPLE LLC EXG 2024-11-08 00810040135293 Safe N Simple SAFE N' SIMPLE LLC EXG 2024-11-08 00810040135309 Safe N Simple SAFE N' SIMPLE LLC EXG 2024-11-08 00810040135231 Safe N Simple SAFE N' SIMPLE LLC EXG 2024-11-08 00810040135286 Safe N Simple SAFE N' SIMPLE LLC EXG 2024-11-08 06974567745886 EMSRUN Wuxi Emsrun Technology Co., Ltd. EXG 2024-05-22 16974567745883 EMSRUN Wuxi Emsrun Technology Co., Ltd. EXG 2024-05-22 10768455204530 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204547 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204615 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204622 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204639 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204646 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204653 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204660 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204677 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204714 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204721 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204745 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204752 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 10768455204769 ESTEEM CONVATEC, PURCHASING DEPARTMENT EXG 2024-03-20 00810040133121 Safe N Simple SAFE N' SIMPLE LLC EXG 2023-11-01 00810040133138 Safe N Simple SAFE N' SIMPLE LLC EXG 2023-11-01 00810040133169 Safe N Simple SAFE N' SIMPLE LLC EXG 2023-11-01