FDA.reportPublic FDA data

Bag Decanter

Primary DI
00813079020066
Brand
Bag Decanter
Company
REMINGTON MEDICAL, INC.
Model
9002-NS
Catalog number
9002-NS
Device description
For aseptic decanting of I.V. fluids from flexible containers.
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHISet, i.V. Fluid transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813079020063PackageGS12In Commercial Distribution
00813079020066PrimaryGS10
80813079020062Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081307902006310813079020063
00813079020066008130790200668130790200660813079020066
8081307902006280813079020062

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous fluid bag spikeA small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle35degree

Contacts#

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

Regulatory Flags#

DUNS number
788472314
Device count
250
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813079020363Breast Needle LocatorBNL-2003BNL-20032020-09-24
00813079020370Breast Needle LocatorBNL-2005BNL-20052020-09-24
00813079020387Breast Needle LocatorBNL-2007BNL-20072020-09-24
00813079020394Breast Needle LocatorBNL-2010BNL-20102020-09-24
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

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Primary DI, Brand, Company table
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00887709190214ICU Medical, Inc.ICU MEDICAL, INC.LHI2026-08-07
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18859299138128ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
18859299138326ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationLHI2026-06-30
10813153027384CodanCodan US CorporationLHI2026-06-25
08699443581898FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
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08699443585315FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585322FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585339FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
10815879021929IV PlusNEXUS MEDICAL, LLCLHI2025-10-03
04063574200425nextaro® va 13, 5 µm Filtersfm medical devices GmbHLHI2025-09-05
10815879021806 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-10-21
08699443580174FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-10-07
10815879021783IV PlusNEXUS MEDICAL, LLCLHI2024-09-27
10815879021745IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
10815879021752IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
04063574200371nextaro® va 15, 5 µm Filtersfm medical devices GmbHLHI2024-09-11
04063574200401nextaro® 20/20, vented, 5 µm Filtersfm medical devices GmbHLHI2024-09-11
08699443580167FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-08-05
04063574200357nextaro® 20/32, vented, 15 µm nominal Filtersfm medical devices GmbHLHI2024-06-05
04063574200272nextaro® 20/20, vented, 15 µm nominal Filtersfm medical devices GmbHLHI2024-04-24
10815879021677 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-04-02
10197344001699MedlineMEDLINE INDUSTRIES, INC.LHI2024-03-05
10815879021660IV PlusNEXUS MEDICAL, LLCLHI2024-03-05