FDA.reportPublic FDA data

Drainage Bag

Primary DI
20886333001433
Brand
Drainage Bag
Company
ARGON MEDICAL DEVICES, INC.
Model
DBAG600H
Catalog number
DBAG600H
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
OTC
false
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
20886333001433PackageGS15In Commercial Distribution
00886333001439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300143320886333001433
00886333001439008863330014398863330014390886333001439

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
140727624
Device count
1
DM exempt
false
Premarket exempt
false
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#

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
00886333001422Drainage BagARGON MEDICAL DEVICES, INC.EXF2016-09-09
00886333001439Drainage BagARGON MEDICAL DEVICES, INC.EXF2016-09-09
20886333001426Drainage 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