FDA.reportPublic FDA data

GamCath HighFlow Dolphin Catheter

Primary DI
37332414110681
Brand
GamCath HighFlow Dolphin Catheter
Company
Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
Model
GAMCATH MS-GDHC-1125 A
Catalog number
114024
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 Hi
Published
2015-10-07
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
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
37332414110681PackageGS15In Commercial Distribution
07332414110680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241411068137332414110681
07332414110680073324141106807332414110680

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, nonimplantableA sterile, 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
Length250Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.
Storage Environment Temperature030 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
333802754
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414110666GamCath HighFlow Dolphin CatheterGAMCATH MS-GDHC-1115 A1140222015-10-07
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
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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