Consulting Wallah › Device Explorer › Catheters & tubes › Peritoneal dialysis catheter, chronic
Device Explorer · FDA GUDID · GMDN 47086

Peritoneal dialysis catheter, 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. It is usually surgically or endoscopically implanted, percutaneo

US‑registered devices70in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription41%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Merit Medical Systems, Inc.5376%
Cook Incorporated1319%
Lifemed Of California23%
Mozarc Medical Us Llc23%

Top labelers

CompanyDevicesShare
Merit Medical Systems, Inc.5376%
Cook Incorporated1319%
Lifemed Of California23%
Mozarc Medical Us Llc23%

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

Brand names on the register (sample)

Flex-Neck®Lifemed Lifecoil Chronic Peritoneal CatheterLifemed Chronic Tenckhoff Peritoneal CatheterCookCOOKTenckhoffRitusArgyle

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 indwelling28
FJSCATHETER, PERITONEAL, LONG-TERM INDWELLING20
GBWCATHETER, PERITONEAL13
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION5
FJSCatheter, Peritoneal, Long-Term Indwelling3
KDJSet, Administration, For Peritoneal Dialysis, Disposable1

GMDN & GCC registration

  • GMDN code 47086 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 41% · 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) · 4Outer Diameter (Millimeter) · 2Lumen/Inner Diameter (Millimeter) · 2

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

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

70 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Peritoneal dialysis catheter, chronic", from 4 companies. The largest labeler is Merit Medical Systems, Inc. with 76% of records.

Which FDA product codes apply?

FJS (Catheter, peritoneal, long-term indwelling), FJS (CATHETER, PERITONEAL, LONG-TERM INDWELLING), GBW (CATHETER, PERITONEAL), DRE (DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION)

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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