FDA.reportPublic FDA data

CLEARLINK/CONTINU-FLO

Primary DI
00085412073682
Brand
CLEARLINK/CONTINU-FLO
Company
BAXTER INTERNATIONAL INC.
Model
2C6256
Catalog number
2C6256
Device description
CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, Large Bore Stopcock Manifold Extension Set, Luer Activated Valve, 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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMGStopcock, i.V. Set
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMGStopcock, I.V. SetGeneral Hospital2
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130245000LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOBaxter Healthcare Corp2013-03-01FMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412073687PackageGS148In Commercial Distribution
00085412073682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541207368750085412073687
00085412073682000854120736820854120736820085412073682

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous line stopcockA sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
005146311
Device count
1
Lot or batch
true
No natural rubber latex
true

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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