FDA.reportPublic FDA data

Drainage Bag

Primary DI
20886333001426
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
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
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

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
00886333209859L-Cath PICC3844663844662026-10-14
00886333006151Skater Nephrostomy Drainage Catheter7556060257556060252026-10-07
00886333006168Skater Nephrostomy Drainage Catheter7556140357556140352026-10-07
00886333006175Skater Nephrostomy Drainage Catheter7556120357556120352026-10-07
00886333006182Skater Nephrostomy Drainage Catheter7556080357556080352026-10-07
00886333006199Skater Nephrostomy Catheter7556100357556100352026-10-07
00886333006205Skater All-Purpose Drainage Catheter7560060207560060202026-10-07
00886333006212Skater All-Purpose Drainage Catheter7560070207560070202026-10-07
00886333006229Skater All-Purpose Drainage Catheter7560120257560120252026-10-07
00886333006236Skater All-Purpose Drainage Catheter7560100257560100252026-10-07
00886333006243Skater All-Purpose Drainage Catheter7560080257560080252026-10-07
00886333006250Skater All-Purpose Drainage Catheter7565140257565140252026-10-07
00886333006267Skater All-Purpose Drainage Catheter7565160257565160252026-10-07
00886333006274Skater All-Purpose Drainage Catheter7565120257565120252026-10-07
00886333006281Skater All-Purpose Drainage Catheter7565100307565100302026-10-07
00886333006298Skater All-Purpose Drainage Catheter7565100257565100252026-10-07
00886333006304Skater All-Purpose Drainage Catheter7565080307565080302026-10-07
00886333006311Skater All-Purpose Drainage Catheter7565080257565080252026-10-07
00886333006328Skater All-Purpose Drainage Catheter7565070257565070252026-10-07
00886333006335Skater All-Purpose Drainage Catheter7565060207565060202026-10-07

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
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
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