Consulting Wallah › Device Explorer › Catheters & tubes › Peritoneal dialysis catheter, acute/chronic
Device Explorer · FDA GUDID · GMDN 47085

Peritoneal dialysis catheter, acute/chronic

A tube used to infuse a solution (dialysate) into the peritoneal cavity, allowing metabolic wastes/fluid to diffuse from the blood to the dialysate using the peritoneum as the dialysing membrane, and capable of being utilized for acute and chronic peritoneal d

US‑registered devices172in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Mozarc Medical Us Llc11567%
Medical Components, Inc.3722%
Medionics International Inc148%
Pfm Medical Incorporated63%

Top labelers

CompanyDevicesShare
Mozarc Medical Us Llc11567%
Medical Components, Inc.3722%
Medionics International Inc148%
Pfm Medical Incorporated63%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/AN/A"""X"" SERIES PD CATHETER""X"" SERIES PD CATHETEV-SERIES PD CatheterI-SERIES PD CatheterI-SERIES PD CATHETERVETA Peritoneal Dialysis CatheterPeritoneal Dialysis CatheterRitusArgyle

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

FDA product codes

CodeNameDevices
FJSCATHETER, PERITONEAL, LONG-TERM INDWELLING148
FJSCatheter, Peritoneal, Long-Term Indwelling26
FJSCatheter, peritoneal, long-term indwelling23
KGZACCESSORIES, CATHETER2
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION2
GAHStylet, Surgical, General & Plastic Surgery1

GMDN & GCC registration

  • GMDN code 47085 · 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) · 117Catheter Gauge (French) · 4Length (Inch) · 2

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

How many peritoneal dialysis catheter, acute/chronic products are registered in the US?

172 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Peritoneal dialysis catheter, acute/chronic", from 4 companies. The largest labeler is Mozarc Medical Us Llc with 67% of records.

Which FDA product codes apply?

FJS (CATHETER, PERITONEAL, LONG-TERM INDWELLING), FJS (Catheter, Peritoneal, Long-Term Indwelling), FJS (Catheter, peritoneal, long-term indwelling), KGZ (ACCESSORIES, CATHETER)

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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