Consulting Wallah › Device Explorer › Catheters & tubes › Double-lumen haemodialysis catheter, nonimplantabl
Device Explorer · FDA GUDID · GMDN 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

US‑registered devices897in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Teleflex Incorporated43048%
Medical Components, Inc.22425%
Mozarc Medical Us Llc20623%
Cook Incorporated121%
Gambro Kathetertechnik Hechingen - Zweigniederlassung Der Gambro Dialysatoren Gmbh101%
Jet Medical, Inc.81%
Nuwellis Inc.61%
Tianck Medical Co., Ltd.10%

Top labelers

CompanyDevicesShare
Teleflex Incorporated43048%
Medical Components, Inc.22425%
Mozarc Medical Us Llc20623%
Cook Incorporated121%
Gambro Kathetertechnik Hechingen - Zweigniederlassung Der Gambro Dialysatoren Gmbh101%
Jet Medical, Inc.81%
Nuwellis Inc.61%
Tianck Medical Co., Ltd.10%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GamCath HighFlow Dolphin CatheterManifoldDUO-SPLIT®DUO-FLOW®Tri-FlowSoft-Line® Duo-Flow®Duo-Flow®Duo-Split®400XLSOFT-LINE®DUO-FLOW®IJSOFT-LINE®DUO-FLOW®400XL IJ400XL IJSOFT-LINE® DUO-FLOW®DUO-FLOW® SIDE X SIDET-3 Triple Lumen CTT-3 Triple Lumen

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MPBCATHETER, HEMODIALYSIS, NON-IMPLANTED679
MPBCatheter, hemodialysis, non-implanted209
FOZCatheter,intravascular,therapeutic,short-term less than 30 d87
NIECATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED55
MPBCatheter, Hemodialysis, Non-Implanted43
FOZCatheter, intravascular, therapeutic, short-term less than 331

GMDN & GCC registration

  • GMDN code 46979 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Catheter Gauge (French) · 438Length (Centimeter) · 416Length (Millimeter) · 10Catheter Working Length (Centimeter) · 4

Use these as the dimensions to specify in a tender line.

How many double-lumen haemodialysis catheter, nonimplantable products are registered in the US?

897 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Double-lumen haemodialysis catheter, nonimplantable", from 8 companies. The largest labeler is Teleflex Incorporated with 48% of records.

Which FDA product codes apply?

MPB (CATHETER, HEMODIALYSIS, NON-IMPLANTED), MPB (Catheter, hemodialysis, non-implanted), FOZ (Catheter,intravascular,therapeutic,short-term less than 30 d), NIE (CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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