GamCath HighFlow Dolphin Catheter

Basic Information

• Brand Name: GamCath HighFlow Dolphin Catheter
• Primary DI: 07332414110765
• Version / Model: GAMCATH MS-GDHC-1115J A
• Catalog Number: 114033
• Company Name: Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
• Labeler DUNS: 333802754
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-07
• Public Version: 6
• Public Version Date: 2023-07-21
• Public Version Status: Update
• Public Device Record Key: e12bd12a-ac60-4d8e-8807-cbb2e1a48924

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MPB	CATHETER, HEMODIALYSIS, NON-IMPLANTED	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46979	Double-lumen haemodialysis catheter, nonimplantable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37332414110766	GS1	CASE	5	In Commercial Distribution
Primary	07332414110765	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K100451	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	11.5	French
Device Size Text, specify			CURVED
Length	150	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight.
• Type: Storage Environment Temperature
• Temperature Range: High: 30 Degrees Celsius