Consulting Wallah › Device Explorer › Catheters & tubes › Indwelling urethral catheterization kit, adult
Device Explorer · FDA GUDID · GMDN 32031

Indwelling urethral catheterization kit, adult

A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary dr

US‑registered devices895in commercial distribution
Companies23labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription95%Rx‑only share
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Share of device records

C. R. Bard, Inc.39044%
Medline Industries, Inc.26630%
Cardinal Health 200, Llc10211%
Cardinal Health, Inc.313%
Hr Pharmaceuticals Inc.222%
Nurse Assist, Inc.222%
Amsino International, Inc.182%
Poiesis Medical, Llc81%

Top labelers

CompanyDevicesShare
C. R. Bard, Inc.39044%
Medline Industries, Inc.26630%
Cardinal Health 200, Llc10211%
Cardinal Health, Inc.313%
Hr Pharmaceuticals Inc.222%
Nurse Assist, Inc.222%
Amsino International, Inc.182%
Poiesis Medical, Llc81%
Deroyal Industries, Inc.61%
Neil Medical Group51%
Ghc Healthcare, Inc.40%
Owens & Minor Distribution, Inc.40%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Disposable Silicone Foley CatheterGLOBAL HEALTHCAREBiotronix Healthcare Foley TraysDirectVisionNeil Medical GroupTMM-FCTruAdvanceTruAdvance®NARNAR KitCookSureStep Foley Tray SystemSureStep Foley Tray System Bardex All-Silicone FBardex® I.C Complete Care® Temp-Sensing Foley CaSureStep Foley Tray System with Bardex LubricathSureStep Foley Tray System with Bard Lubri-Sil T

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

FDA product codes

CodeNameDevices
OHRCatheter care tray253
EZLCATHETER, RETENTION TYPE, BALLOON182
MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES182
EZCCATHETER, COUDE141
KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER110
FCMTray, catheterization, sterile urethral, with or without cat92

GMDN & GCC registration

  • GMDN code 32031 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 95% · 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) · 852Total Volume (Milliliter) · 196Outer Diameter (Inch) · 8Length (Inch) · 4Width (Inch) · 2

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

How many indwelling urethral catheterization kit, adult products are registered in the US?

895 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Indwelling urethral catheterization kit, adult", from 23 companies. The largest labeler is C. R. Bard, Inc. with 44% of records.

Which FDA product codes apply?

OHR (Catheter care tray), EZL (CATHETER, RETENTION TYPE, BALLOON), MJC (CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES), EZC (CATHETER, COUDE)

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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