FDA.reportPublic FDA data

Drainage Bag

Primary DI
00813079020004
Brand
Drainage Bag
Company
REMINGTON MEDICAL, INC.
Model
600-D
Catalog number
600-D
Device description
Size: 600 ml
Published
2016-09-21
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
10813079020001PackageGS125In Commercial Distribution
20813079020008PackageGS120In Commercial Distribution
00813079020004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081307902000110813079020001
2081307902000820813079020008
00813079020004008130790200048130790200040813079020004

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
Total Volume600Milliliter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-0057Quality@Remmed.com

Regulatory Flags#

DUNS number
788472314
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813079021506Remington Medical, Inc Disposable Extension CablePK-155-BPK-155-B2026-04-10
00813079022664VascuChek TransceiverVC-TRX-02VC-TRX-022025-11-27
00813079022671VascuChek Speaker DockVC-SD-01VC-SD-012025-11-27
00813079022688VascuChek KitVC-KIT-02VC-KIT-022025-11-27
00813079022008Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1410BNAC-1410B2025-01-17
00813079022015Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1412BNAC-1412B2025-01-17
00813079022022Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416BNAC-1416B2025-01-17
00813079022039Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1420BNAC-1420B2025-01-17
00813079022046Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1610BNAC-1610B2025-01-17
00813079022053Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1616BNAC-1616B2025-01-17
00813079022060Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1620BNAC-1620B2025-01-17
00813079022077Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1810BNAC-1810B2025-01-17
00813079022084Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416NAC-14162025-01-17
00813079022091Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1825NAC-18252025-01-17
00813079022107Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1410BNAC-1410B2025-01-17
00813079022114Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1412MNAC-1412M2025-01-17
00813079022121Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416MNAC-1416M2025-01-17
00813079022138Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1420MNAC-1420M2025-01-17
00813079022145Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1610MNAC-1610M2025-01-17
00813079022152Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1616MNAC-1616M2025-01-17

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
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