GUDIDData
gudid Primary ID: GAMCATH MS-GDHC-1315J A

GamCath HighFlow Dolphin Catheter (UDI GAMCATH MS-GDHC-1315J A)

Manufactured by Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GamCath HighFlow Dolphin Catheter - Primary ID GAMCATH MS-GDHC-1315J A

Device Regulatory Overview

The GamCath HighFlow Dolphin Catheter (Model/Catalog Number: GAMCATH MS-GDHC-1315J A) is a medical device manufactured by Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH. This product is indexed under FDA Product Code / Category Classification MPB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
GAMCATH MS-GDHC-1315J A
Product Code / EMDN
MPB
Device Name
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.
Database Sync Date
2026-08-09 09:10:27

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of GamCath HighFlow Dolphin Catheter?

The registered manufacturer of record for GamCath HighFlow Dolphin Catheter is Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH.

What is the Primary UDI-DI identifier for GamCath HighFlow Dolphin Catheter?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GAMCATH MS-GDHC-1315J A.

What classification code is assigned to this device?

This device is registered under product classification code MPB.

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