Home GUDID 00661613318038 Biliary Drainage Kit
Primary DI 00661613318038
Brand Biliary Drainage Kit
Company Marlen Manufacturing And Development Co.
Model 31803
Device description Biliary Drainage Kit BK-6
Published 2026-05-03
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 EXF Bag, Bile Collecting
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EXF Bag, Bile Collecting Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00661613318038 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 00661613318038 00661613318038 661613318038 0661613318038
GMDN Terms# Term, Definition table Term Definition Biliary drain A flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device.
Regulatory Flags# DUNS number 004220711 Device count 1 Premarket exempt true Lot or batch true Manufacturing 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 00884450859773 Merit Drainage Depot™ Merit Medical Systems, Inc. EXF 2025-05-29 10884450859770 Merit Drainage Depot™ Merit Medical Systems, Inc. EXF 2025-05-29 00817640020479 Drainage Bag URESIL, LLC EXF 2022-06-03 20817640020473 Drainage Bag URESIL, LLC EXF 2022-06-03 00817640020554 Optimus Gravity Drainage Bag URESIL, LLC EXF 2021-11-04 00817640020561 Optimus Gravity Drainage Bag URESIL, LLC EXF 2021-11-04 10817640020551 Gravity Drainage Bag URESIL, LLC EXF 2021-11-04 10817640020568 Gravity Drainage Bag URESIL, LLC EXF 2021-11-04 H862PDC360 Drainage Bag URESIL, LLC EXF 2017-09-11 H862TC6000 Gravity Drainage Bag URESIL, LLC EXF 2017-09-11 H862TC600L0 Gravity Drainage Bag URESIL, LLC EXF 2017-09-11 H862PDC362 Gravity Drainage Bag URESIL, LLC EXF 2017-09-11 H862TC6002 Gravity Drainage Bag URESIL, LLC EXF 2017-09-11 H862TC600L2 Gravity Drainage Bag URESIL, LLC EXF 2017-09-11 00884450025604 Merit Drainage Depot™ Merit Medical Systems, Inc. EXF 2016-11-03 10884450025601 Merit Drainage Depot™ Merit Medical Systems, Inc. EXF 2016-11-03 00884450008256 Merit Drainage Depot™ Merit Medical Systems, Inc. EXF 2016-09-24 00884450232231 Merit Drainage Depot™ Merit Medical Systems, Inc. EXF 2016-09-24 10884450008253 Merit Drainage Depot™ Merit Medical Systems, Inc. EXF 2016-09-24 10884450232238 Merit Drainage Depot™ Merit Medical Systems, Inc. EXF 2016-09-24 00813079020004 Drainage Bag REMINGTON MEDICAL, INC. EXF 2016-09-21 20813079020008 Drainage Bag REMINGTON MEDICAL, INC. EXF 2016-09-21 00886333001422 Drainage Bag ARGON MEDICAL DEVICES, INC. EXF 2016-09-09 00886333001439 Drainage Bag ARGON MEDICAL DEVICES, INC. EXF 2016-09-09 20886333001426 Drainage Bag ARGON MEDICAL DEVICES, INC. EXF 2016-09-09 20886333001433 Drainage Bag ARGON MEDICAL DEVICES, INC. EXF 2016-09-09 00801741036873 VacuBag Bard Access Systems, Inc. EXF 2015-12-04 10801741036870 VacuBag Bard Access Systems, Inc. EXF 2015-12-04 00801741036880 Navarre Bard Access Systems, Inc. EXF 2015-11-20 10801741036887 Bard Drainage Bag Bard Access Systems, Inc. EXF 2015-11-20