FDA.reportPublic FDA data

CLEARLINK/CONTINU-FLO/CONTROL-A-FLO

Primary DI
00085412069302
Brand
CLEARLINK/CONTINU-FLO/CONTROL-A-FLO
Company
BAXTER HEALTHCARE CORPORATION
Model
2C8895
Catalog number
2C8895
Device description
CONTINU-FLO Solution Set with CONTROL-A-FLO Regulator, 2 Luer Activated Valves, 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
FPASet, administration, intravascular

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121634000INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORBaxter Healthcare Corporation2012-06-29FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412069307PackageGS148In Commercial Distribution
00085412069302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541206930750085412069307
00085412069302000854120693020854120693020085412069302

GMDN Terms#

Term, Definition table
TermDefinition
Medical tubing clip/clamp, temporary, dial-calibratedA non-sterile manual device designed to control the infusion rate through gravity intravenous administration infusion sets. It typically consists of a mechanism that regulates the flow using a calibrated dial that permits control of the flow rate in a given range (e.g., from a few to 250 ml/h); it may also include a lateral clamp for temporary interruption of the infusion and/or a check valve to permit parallel infusion. The device is used in-line with gravity infusion administration sets. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
005083209
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412046327CLEARLINK/CONTINU-FLO2C85712C85712016-09-24
00085412048451CLEARLINK/CONTINU-FLO2H85192H85192016-09-24
00085412080901CLEARLINK/CONTINU-FLO2H85372H85372016-09-24
00085412676630DUO-VENT2R84042R84042023-07-11
00085412478296BaxterH93813501H938135012026-05-29
00085412478302BaxterH93813601H938136012026-05-29
00085412004945INTERLINK2N33792N33792016-09-24
00085412004983INTERLINK2N33992N33992016-09-24
00085412048895CLEARLINK2N83992N83992016-09-24
00085412002125INTERLINK2C64022C64022016-09-24
00085412003948INTERLINK/DUO-VENT2C64192C64192016-09-24
00085412017716INTERLINK/CONTINU-FLO3C00623C00622016-09-24
00085412046389CLEARLINK/DUO-VENT2C88752C88752016-09-24
00085412048499CLEARLINK/DUO-VENT2H84802H84802016-09-24
00085412048932CLEARLINK2C84012C84012016-09-24
00085412048949CLEARLINK2C84022C84022016-09-24
00085412048987CLEARLINK/CONTINU-FLO2C85462C85462016-09-24
00085412048994CLEARLINK/CONTINU-FLO2C85192C85192016-09-24
00085412049090CLEARLINK2H84012H84012016-09-24
00085412051703CLEARLINK/CONTINU-FLO2C85152C85152016-09-24

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05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
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05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
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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
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00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
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