FDA.reportPublic FDA data

GamCath HighFlow Dolphin Catheter

Primary DI
07332414110666
Brand
GamCath HighFlow Dolphin Catheter
Company
Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
Model
GAMCATH MS-GDHC-1115 A
Catalog number
114022
Device description
Short-term use to obtain vasular access in patients with acute or chronic renal failure. The GamCath HighFlow Dolphin Catheter combines the GamCath HighFlow Catheter with an additional coating based on a block copolymer.
Published
2015-10-07
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
MPBCATHETER, HEMODIALYSIS, NON-IMPLANTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPBCatheter, Hemodialysis, Non-ImplantedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100451000GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132Gambro Renal Products, Inc.2010-12-21MPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414110667PackageGS15In Commercial Distribution
07332414110666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241411066737332414110667
07332414110666073324141106667332414110666

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, nonimplantableA flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge11.5French
Device Size Text, specify0
Length150Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.
Storage Environment Temperature030 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
333802754
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414110673GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1120 A1140232015-10-07
07332414110680GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1125 A1140242015-10-07
07332414110703GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1320 A1140262015-10-07
07332414110710GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1325 A1140272015-10-07
07332414110765GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1115J A1140332015-10-07
07332414110772GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1120J A1140342015-10-07
07332414110789GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1315J A1140352015-10-07
07332414110796GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1320J A1140362015-10-07
07332414110697GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1315 A1140252015-10-07
37332414110667GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1115 A1140222015-10-07
37332414110674GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1120 A1140232015-10-07
37332414110681GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1125 A1140242015-10-07
37332414110698GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1315 A1140252015-10-07
37332414110704GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1320 A1140262015-10-07
37332414110711GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1325 A1140272015-10-07
37332414110766GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1115J A1140332015-10-07
37332414110773GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1120J A1140342015-10-07
37332414110780GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1315J A1140352015-10-07
37332414110797GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1320J A1140362015-10-07

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