FDA.reportPublic FDA data

Drainage Bag

Primary DI
H862PDC360
Brand
Drainage Bag
Company
URESIL, LLC
Model
PDC-36
Catalog number
PDC-36
Device description
Percutaneous Drainage Catheter Connector Tubing
Published
2017-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXFBag, Bile Collecting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXFBag, Bile CollectingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H862PDC362PackageHIBCC75In Commercial Distribution
H862PDC360PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound/centesis drainage receptacleA sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length36Centimeter

Contacts#

Phone, Email table
PhoneEmail
1-800-538-7374SALES@URESIL.COM

Regulatory Flags#

DUNS number
192559557
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H862TC600L0Gravity Drainage BagTC600LTC600L2017-09-11
H862TFDR0Tru-Fix Catheter Fixation KitTFD-RTFD-R2016-08-31
H862TFK060Tru-Fix Catheter Fixation KitTFK-06TFK-062016-08-31
H862TFK080Tru-Fix Catheter Fixation KitTFK-08TFK-082016-08-31
H862TFK100Tru-Fix Catheter Fixation KitTFK-10TFK-102016-08-31
H862TFK120Tru-Fix Catheter Fixation KitTFK-12TFK-122016-08-31
H862TFK140Tru-Fix Catheter Fixation KitTFK-14TFK-142016-08-31
H862TFK160Tru-Fix Catheter Fixation KitTFK-16TFK-162016-08-31
00817640020639Tru-Fix Catheter Fixation KitTFD-RTFD-R2022-05-12
00817640020646Tru-Fix Catheter Fixation KitTFK-06TFK-062022-05-12
00817640020653Tru-Fix Catheter Fixation KitTFK-08TFK-082022-05-12
00817640020660Tru-Fix Catheter Fixation KitTFK-10TFK-102022-05-12
00817640020677Tru-Fix Catheter Fixation KitTFK-12TFK-122022-05-12
00817640020684Tru-Fix Catheter Fixation KitTFK-14TFK-142022-05-12
00817640020691Tru-Fix Catheter Fixation KitTFK-16TFK-162022-05-12
H862DFALL0Aspiration and Flush AssemblyDFA-LLDFA-LL2016-08-29
H862TV11100Thora-Vent Thoracic VentTV11-10TV11-102016-09-07
H862TV11130Thora-Vent Thoracic VentTV11-13TV11-132016-09-07
H862TV13100Thora-Vent Thoracic VentTV13-10TV13-102016-09-07
H862TV13130Thora-Vent Thoracic VentTV13-13TV13-132016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00661613318038Biliary Drainage KitMarlen Manufacturing And Development Co.EXF2026-05-03
00884450859773Merit Drainage Depot™Merit Medical Systems, Inc.EXF2025-05-29
10884450859770Merit Drainage Depot™Merit Medical Systems, Inc.EXF2025-05-29
00817640020479Drainage BagURESIL, LLCEXF2022-06-03
20817640020473Drainage BagURESIL, LLCEXF2022-06-03
00817640020554Optimus Gravity Drainage BagURESIL, LLCEXF2021-11-04
00817640020561Optimus Gravity Drainage BagURESIL, LLCEXF2021-11-04
10817640020551Gravity Drainage BagURESIL, LLCEXF2021-11-04
10817640020568Gravity Drainage BagURESIL, LLCEXF2021-11-04
H862TC6000Gravity Drainage BagURESIL, LLCEXF2017-09-11
H862TC600L0Gravity Drainage BagURESIL, LLCEXF2017-09-11
H862PDC362Gravity Drainage BagURESIL, LLCEXF2017-09-11
H862TC6002Gravity Drainage BagURESIL, LLCEXF2017-09-11
H862TC600L2Gravity Drainage BagURESIL, LLCEXF2017-09-11
00884450025604Merit Drainage Depot™Merit Medical Systems, Inc.EXF2016-11-03
10884450025601Merit Drainage Depot™Merit Medical Systems, Inc.EXF2016-11-03
00884450008256Merit Drainage Depot™Merit Medical Systems, Inc.EXF2016-09-24
00884450232231Merit Drainage Depot™Merit Medical Systems, Inc.EXF2016-09-24
10884450008253Merit Drainage Depot™Merit Medical Systems, Inc.EXF2016-09-24
10884450232238Merit Drainage Depot™Merit Medical Systems, Inc.EXF2016-09-24
00813079020004Drainage BagREMINGTON MEDICAL, INC.EXF2016-09-21
20813079020008Drainage BagREMINGTON MEDICAL, INC.EXF2016-09-21
00886333001422Drainage BagARGON MEDICAL DEVICES, INC.EXF2016-09-09
00886333001439Drainage BagARGON MEDICAL DEVICES, INC.EXF2016-09-09
20886333001426Drainage BagARGON MEDICAL DEVICES, INC.EXF2016-09-09
20886333001433Drainage BagARGON MEDICAL DEVICES, INC.EXF2016-09-09
00801741036873VacuBagBard Access Systems, Inc.EXF2015-12-04
10801741036870VacuBagBard Access Systems, Inc.EXF2015-12-04
00801741036880NavarreBard Access Systems, Inc.EXF2015-11-20
10801741036887Bard Drainage BagBard Access Systems, Inc.EXF2015-11-20