FDA.reportPublic FDA data

CONTINU-FLO/DUO-VENT

Primary DI
50085412079702
Brand
CONTINU-FLO/DUO-VENT
Company
BAXTER INTERNATIONAL INC.
Model
ACT5543
Catalog number
ACT5543
Device description
CONTINU-FLO Solution Set with DUO-VENT Spike, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar
Published
2016-09-24
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142011000SOLUTION SET/EXTENSION SETBaxter Healthcare Corporation2014-08-18FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412079702PackageGS148In Commercial Distribution
00085412079707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541207970250085412079702
00085412079707000854120797070854120797070085412079707

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
005146311
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412002286INTERLINK/CONTINU-FLO2C65722C65722016-09-24
00085412002347INTERLINK2C66072C66072016-09-24
00085412002361INTERLINK2C66312C66312016-09-24
00085412003955INTERLINK2C66062C66062016-09-24
00085412004921INTERLINK2N33762N33762016-09-24
00085412013619INTERLINK1C83331C83332016-09-24
00085412014135INTERLINK1C84541C84542016-09-24
00085412017853INTERLINK/CONTINU-FLO3C00913C00912016-09-24
00085412051314CLEARLINK2N83772N83772016-09-24
00085412079677CLEARLINK/CONTINU-FLOACT8570ACT85702016-09-24
00085412079707CONTINU-FLO/DUO-VENTACT5543ACT55432016-09-24
00085412082592CLEARLINK/INTERLINK/DUO-VENTEMS3160EMS31602016-09-24
00085412000985Arthromatic/Uromatic2C40062C40062016-09-24
00085412001005Arthromatic/Uromatic2C40142C40142016-09-24
00085412014869Baxter1C86141C86142016-09-24
00085412000978Arthromatic/Uromatic2C40052C40052016-09-24
00085412001050Arthromatic/Uromatic2C40402C40402016-09-24
00085412001067Arthromatic/Uromatic2C40412C40412016-09-24
00085412004136Baxter2C76272C76272016-09-24
00085412027388VIAL-MATE2B80712B80712016-09-24

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05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
04046955836383Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
04046955836406Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06