Consulting Wallah › Device Explorer › Catheters & tubes › Indwelling urethral drainage balloon catheter, non
Device Explorer · FDA GUDID · GMDN 34917

Indwelling urethral drainage balloon catheter, non-antimicrobial

A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary draina

US‑registered devices2,164in commercial distribution
Companies34labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Teleflex Incorporated50623%
Well Lead Medical Co.,Ltd38718%
C. R. Bard, Inc.35016%
Cardinal Health 200, Llc1788%
Coloplast A/S1095%
Cardinal Health, Inc.954%
Mckesson Medical-Surgical Inc.774%
Amsino International, Inc.683%

Top labelers

CompanyDevicesShare
Teleflex Incorporated50623%
Well Lead Medical Co.,Ltd38718%
C. R. Bard, Inc.35016%
Cardinal Health 200, Llc1788%
Coloplast A/S1095%
Cardinal Health, Inc.954%
Mckesson Medical-Surgical Inc.774%
Amsino International, Inc.683%
Fortune Medical Instrument Corp.673%
Medline Industries, Inc.583%
Hr Pharmaceuticals Inc.482%
Cook Incorporated412%

Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Latex Foley CatheterAll Silicone Foley CatheterDisposable Silicone Foley CatheterDisposable Silicone Foley Catheter Three-way 22FDisposable Silicone Foley Catheter Three-way 20FDisposable Silicone Foley Catheter Two-way 24FrDisposable Silicone Foley Catheter Two-way 20FrDisposable Silicone Foley Catheter Two-way 18FrDisposable Silicone Foley Catheter Two-way 16FrFLUME catheterMediplusSilicone 2-way Foley Balloon Catheter (Grooved BSilicone 2-way Foley Balloon Catheter (Standard Silicone 2-way Foley Balloon Catheter Tiemann TiSilicone 2-way Foley Balloon Catheter (IntegrateSilicone 2-way Foley Catheter Tiemann Tip (Stand

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

FDA product codes

CodeNameDevices
KODCATHETER, UROLOGICAL704
EZLCatheter, Retention Type, Balloon554
EZLCATHETER, RETENTION TYPE, BALLOON498
MJCCatheter, Urological (Antimicrobial) And Accessories212
EZCCATHETER, COUDE137
FBWFILIFORM AND FILIFORM FOLLOWER58

GMDN & GCC registration

  • GMDN code 34917 · non‑implantable
  • Single‑use 99% · sterile 99% · Rx‑only 92% · 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) · 695Height (Inch) · 292Length (Inch) · 291Width (Inch) · 291Total Volume (Milliliter) · 153Outer Diameter (Millimeter) · 60

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

How many indwelling urethral drainage balloon catheter, non-antimicrobial products are registered in the US?

2,164 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Indwelling urethral drainage balloon catheter, non-antimicrobial", from 34 companies. The largest labeler is Teleflex Incorporated with 23% of records.

Which FDA product codes apply?

KOD (CATHETER, UROLOGICAL), EZL (Catheter, Retention Type, Balloon), EZL (CATHETER, RETENTION TYPE, BALLOON), MJC (Catheter, Urological (Antimicrobial) And Accessories)

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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