Consulting Wallah › Device Explorer › Catheters & tubes › Triple-lumen haemodialysis catheter
Device Explorer · FDA GUDID · GMDN 61629

Triple-lumen haemodialysis catheter

A sterile, flexible, triple-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access to: 1) conduct blood from a patient and return it after extracorporeal circulation, primarily during haem

US‑registered devices223in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Mozarc Medical Us Llc7835%
Bard Access Systems, Inc.7634%
Medical Components, Inc.6931%

Top labelers

CompanyDevicesShare
Mozarc Medical Us Llc7835%
Bard Access Systems, Inc.7634%
Medical Components, Inc.6931%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

12F TRI-FLOW TRIPLE LUMEN CATHETERTRIO-CT®TRIO CT®T-3 Triple Lumen CTT-3T-3TRIO-CT12F TRI-FLOW TRIPLE LUMEN CATHETER12F TRI-FLOW TPowerTrialysisPower-TrialysisPower-Trialysis Slim-Cath catheterPower-Trialysis catheterPower-Trialysis Alphacurve catheterMAHURKARMAHURKAR Elite

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

FDA product codes

CodeNameDevices
NIECATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED156
NIECatheter, hemodialysis, triple lumen, non-implanted97
NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted1

GMDN & GCC registration

  • GMDN code 61629 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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

Length (Centimeter) · 166Catheter Gauge (French) · 165

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

How many triple-lumen haemodialysis catheter products are registered in the US?

223 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Triple-lumen haemodialysis catheter", from 3 companies. The largest labeler is Mozarc Medical Us Llc with 35% of records.

Which FDA product codes apply?

NIE (CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED), NIE (Catheter, hemodialysis, triple lumen, non-implanted), 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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