Consulting Wallah › Device Explorer › Catheters & tubes › Single-administration urethral drainage/irrigation
Device Explorer · FDA GUDID · GMDN 34930

Single-administration urethral drainage/irrigation catheter

A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a

US‑registered devices114in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Owens & Minor Distribution, Inc.2219%
Teleflex Incorporated2018%
Well Lead Medical Co.,Ltd1715%
Cardinal Health, Inc.1412%
Cardinal Health 200, Llc1412%
Dynarex Corporation1110%
Fresenius Kabi Ag98%
Neochild, Llc44%

Top labelers

CompanyDevicesShare
Owens & Minor Distribution, Inc.2219%
Teleflex Incorporated2018%
Well Lead Medical Co.,Ltd1715%
Cardinal Health, Inc.1412%
Cardinal Health 200, Llc1412%
Dynarex Corporation1110%
Fresenius Kabi Ag98%
Neochild, Llc44%
Icu Medical, Inc.33%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PVC Urethral CatheterTransfer SetTwin Transfer SetRUSCHIntermittent Catheter, Female, 16 FrIntermittent Catheter, Female, 14 FrIntermittent Catheter, Female, 12 FrIntermittent Catheter, Female, 10 FrIntermittent Catheter, Female, 8 FrIntermittent Catheter, Male, 18 FrIntermittent Catheter, Male, 16 FrIntermittent Catheter, Male, 14 FrIntermittent Catheter, Male, 12 FrIntermittent Catheter, Male, 10 FrIntermittent Catheter, Male, 8 FrDover

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

FDA product codes

CodeNameDevices
KODCATHETER, UROLOGICAL39
EZDCatheter, Straight28
EZDCatheter, straight22
EZLCATHETER, RETENTION TYPE, BALLOON12
GBXCatheter, Irrigation9
KODCatheter, urological6

GMDN & GCC registration

  • GMDN code 34930 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 96% · OTC 1%
  • 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) · 20Total Volume (Milliliter) · 17Outer Diameter (Millimeter) · 12Length (Inch) · 3Length (Centimeter) · 1Length (Millimeter) · 1

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

How many single-administration urethral drainage/irrigation catheter products are registered in the US?

114 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Single-administration urethral drainage/irrigation catheter", from 9 companies. The largest labeler is Owens & Minor Distribution, Inc. with 19% of records.

Which FDA product codes apply?

KOD (CATHETER, UROLOGICAL), EZD (Catheter, Straight), EZD (Catheter, straight), EZL (CATHETER, RETENTION TYPE, BALLOON)

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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