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Device Explorer · FDA GUDID · GMDN 37278

Double-lumen haemodialysis catheter, implantable

An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during

US‑registered devices1,859in commercial distribution
Companies11labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription95%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Teleflex Incorporated44724%
Medical Components, Inc.36920%
Merit Medical Systems, Inc.30316%
Bard Access Systems, Inc.24113%
Mozarc Medical Us Llc18410%
Ameco Medical Industries1086%
Angiodynamics, Inc.915%
Navilyst Medical, Inc.452%

Top labelers

CompanyDevicesShare
Teleflex Incorporated44724%
Medical Components, Inc.36920%
Merit Medical Systems, Inc.30316%
Bard Access Systems, Inc.24113%
Mozarc Medical Us Llc18410%
Ameco Medical Industries1086%
Angiodynamics, Inc.915%
Navilyst Medical, Inc.452%
Bard Peripheral Vascular, Inc.362%
Marvao Medical Devices Limited251%
Phase One Medical Llc101%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Amecath X split catheterAmecath Twincath catheterAmecath Y split catheterAmecath dual lumen catheterNexSite HD Hemodialysis CatheterNexSite™ HD Split Tip Hemodialysis CatheterNexSite HD Split Tip Hemodialysis CatheterNexSite HD Split Tip CatheterNexSite HD Split TIp Hemodialysis CatheterMEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERSPLIT STREAMSLX HEMO-CATH®SLX Hemo-Cath®HEMO-FLOW®HEMO-CATH® SILICONESPLIT CATH® III

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

FDA product codes

CodeNameDevices
MSDCatheter, hemodialysis, implanted2,140
PEHHemodialysis Catheter Luer End Cap437
MSDCatheter, Hemodialysis, Implanted181
LFJCATHETER, SUBCLAVIAN90
MPBCATHETER, HEMODIALYSIS, NON-IMPLANTED82
MPBCatheter, hemodialysis, non-implanted47

GMDN & GCC registration

  • GMDN code 37278 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 95% · 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) · 1,158Catheter Gauge (French) · 1,108Needle Gauge (Gauge) · 67Outer Diameter (Millimeter) · 66Length (Inch) · 2

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

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

1,859 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Double-lumen haemodialysis catheter, implantable", from 11 companies. The largest labeler is Teleflex Incorporated with 24% of records.

Which FDA product codes apply?

MSD (Catheter, hemodialysis, implanted), PEH (Hemodialysis Catheter Luer End Cap), MSD (Catheter, Hemodialysis, Implanted), LFJ (CATHETER, SUBCLAVIAN)

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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