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Device Explorer · FDA GUDID · GMDN 61494

Vascular port/catheter

A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous

US‑registered devices711in commercial distribution
Companies10labelers on GUDID
Single‑use100%of device records
Sterile98%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Bard Access Systems, Inc.23733%
Angiodynamics, Inc.11015%
Icu Medical, Inc.10214%
Medical Components, Inc.10114%
Pfm Medical Incorporated578%
Navilyst Medical, Inc.426%
Cook Incorporated325%
Perouse Medical162%

Top labelers

CompanyDevicesShare
Bard Access Systems, Inc.23733%
Angiodynamics, Inc.11015%
Icu Medical, Inc.10214%
Medical Components, Inc.10114%
Pfm Medical Incorporated578%
Navilyst Medical, Inc.426%
Cook Incorporated325%
Perouse Medical162%
Vygon Corporation101%
Portal Access, Inc.41%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PEROUSE MEDICALPolysitePRO-FUSE®PRO-FUSE® LOW PROFILE CT PORTPro-Fuse® Low Profile CT PortDIGNITY®DIGNITY® CT PORTDignity®Titanium Mid-Size CT PortDignity® Titanium Mid-Size CT PortDignity® Titanium Low Profile CT PortDignity® Titanium Mid-Sized CT PortPro-Fuse® CT PortDignity® Low Profile CT PortDignity®Mid-Sized CT PortFLEXI-PORTVYGON

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

FDA product codes

CodeNameDevices
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1,248
LJTPort & Catheter, Implanted, Subcutaneous, Intravascular48
FPASet, administration, intravascular35
PXKVascular Access Port Kit20
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPA7
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE2

GMDN & GCC registration

  • GMDN code 61494 · implantable
  • Single‑use 100% · sterile 98% · Rx‑only 98% · 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) · 541Length (Centimeter) · 493Outer Diameter (Millimeter) · 281Lumen/Inner Diameter (Millimeter) · 158Needle Gauge (Gauge) · 91Pressure (Pound per Square Inch) · 26

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

How many vascular port/catheter products are registered in the US?

711 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vascular port/catheter", from 10 companies. The largest labeler is Bard Access Systems, Inc. with 33% of records.

Which FDA product codes apply?

LJT (PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR), LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), FPA (Set, administration, intravascular), PXK (Vascular Access Port Kit)

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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