Indwelling urethral drainage balloon catheter, antimicrobial — 124 US-registered devices, 1 companies, FDA product codes | Device Explorer

Name: Indwelling urethral drainage balloon catheter, antimicrobial — US-registered devices
Creator: Consulting Wallah
License: https://creativecommons.org/licenses/by-nc-nd/4.0/

Share of device records

C. R. Bard, Inc.124100%

Top labelers

Company	Devices	Share
C. R. Bard, Inc.	124	100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Bardex® Lubri-Sil® I.C. All-Silicone Foley CatheBardex® I.C. Temperature-Sensing Foley CatheterBardex® I.C. Temperature Sensing Foley CatheterBardex® Lubri-Sil® I.C. All-Silicone Temp SensinBardex® Lubri-Sil® I.C. Temperature-Sensing All-Lubri-Sil® I.C. Temperature-Sensing All-SiliconeBardex® I.C. Foley CatheterBardex® I.C. Short Tip Foley CatheterBardex® I.C. Tiemann Model Coude Tip Foley CatheBardex® I.C. Councill Model Foley CatheterBardex® I.C. Carson Model Coude Tip Foley Cathet

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

FDA product codes

Code	Name	Devices
MJC	CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES	110
EZL	CATHETER, RETENTION TYPE, BALLOON	67
KOD	CATHETER, UROLOGICAL	6

GMDN & GCC registration

GMDN code 34096 · non‑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

Catheter Gauge (French) · 155Total Volume (Milliliter) · 39

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

Indwelling urethral drainage balloon catheter, non-antimicro2,164 devices · 34 companies

Indwelling urethral catheterization kit, adult895 devices · 23 companies

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

124 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, antimicrobial", from 1 companies. The largest labeler is C. R. Bard, Inc. with 100% of records.

Which FDA product codes apply?

MJC (CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES), EZL (CATHETER, RETENTION TYPE, BALLOON), KOD (CATHETER, UROLOGICAL)

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.