FDA.reportPublic FDA data

Drainage Bag

Primary DI
00886333001422
Brand
Drainage Bag
Company
ARGON MEDICAL DEVICES, INC.
Model
DBAG600
Catalog number
DBAG600
Device description
Drainage Bag 600ml
Published
2016-09-09
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980005000MANAN D BAGMedical Device Technologies, Inc.1998-01-30EXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333001426PackageGS120In Commercial Distribution
00886333001422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300142620886333001426
00886333001422008863330014228863330014220886333001422

GMDN Terms#

Term, Definition table
TermDefinition
Bile collection bagA plastic sac intended to be used to collect bile from a duodenal drainage tube. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333210893Guidewire3951263951262016-09-21
00886333001408Skin Fix8025000008025000002022-07-14
00886333217618Skater™ Fix8025000018025000012022-07-14
00886333226320Co-Axial Introducer NeedleMCXS1620BXMCXS1620BX2022-07-21
00886333000005SKATER™ Drainage Catheter751106025E7511060252022-07-11
00886333000012SKATER™ Drainage Catheter751106035E7511060352022-07-12
00886333000029SKATER™ Drainage Catheter751107025E7511070252022-07-12
00886333000036SKATER™ Drainage Catheter751107035E7511070352022-07-11
00886333000043SKATER™ Drainage Catheter751108025E7511080252022-07-11
00886333000067SKATER™ Drainage Catheter751110025E7511100252022-07-12
00886333000074SKATER™ Drainage Catheter751110035E7511100352022-07-12
00886333000081SKATER™ Drainage Catheter751112025E7511120252022-07-13
00886333000098SKATER™ Drainage Catheter751112035E7511120352022-07-12
00886333000104SKATER™ Drainage Catheter751114025E7511140252022-07-12
00886333000111SKATER™ Drainage Catheter755106025E7551060252022-07-13
00886333000128SKATER™ Drainage Catheter755106035E7551060352022-07-12
00886333000135SKATER™ Drainage Catheter755107025E7551070252022-07-13
00886333000142SKATER™ Drainage Catheter755107035E7551070352022-07-12
00886333000159SKATER™ Drainage Catheter755108025E7551080252022-07-12
00886333000166SKATER™ Drainage Catheter 755108035E7551080352022-07-13

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
H862PDC360Drainage BagURESIL, LLCEXF2017-09-11
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
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