AccessGUDID - DEVICE: GamCath HighFlow Dolphin Catheter (07332414110666)

GUDID

Device Identifier (DI) Information

Brand Name: GamCath HighFlow Dolphin Catheter
Version or Model: GAMCATH MS-GDHC-1115 A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 114022
Company Name: Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH

Primary DI Number: 07332414110666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333802754 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Double-lumen haemodialysis catheter, nonimplantable	A 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.

GMDN Preferred Term Name

GMDN Definition

Double-lumen haemodialysis catheter, nonimplantable

A 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.

FDA Product Code

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Product Code	Product Code Name
MPB	CATHETER, HEMODIALYSIS, NON-IMPLANTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100451	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.
Storage Environment Temperature: less than 30 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Length: 150 Millimeter
Catheter Gauge: 11.5 French
Device Size Text, specify: STRAIGHT

Device Record Status

Public Device Record Key: afe0600b-0d2a-4a87-8cb5-50441862c7cf
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 07, 2015