Consulting Wallah › Device Explorer › Catheters & tubes › Intermittent urethral catheterization kit
Device Explorer · FDA GUDID · GMDN 47778

Intermittent urethral catheterization kit

A collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through the

US‑registered devices58in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Amsino International, Inc.3560%
Hr Pharmaceuticals Inc.814%
Go Medical Industries Pty. Ltd.610%
Medline Industries, Inc.59%
Sterigear, Llc23%
Ghc Healthcare, Inc.12%
Biotronix Healthcare Industries, Inc.12%

Top labelers

CompanyDevicesShare
Amsino International, Inc.3560%
Hr Pharmaceuticals Inc.814%
Go Medical Industries Pty. Ltd.610%
Medline Industries, Inc.59%
Sterigear, Llc23%
Ghc Healthcare, Inc.12%
Biotronix Healthcare Industries, Inc.12%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GLOBAL HEALTHCARETruCathSteriGearBiotronix Healthcare Urethral Catheter TraysMEDLINEAMSure® Preconnected Urethral TrayAMSure® Foley Insertion TrayAMSure® Urethral Catheterization Tray 15FrAMSure® Urethral Catheterization TrayAMSure® Urethral Self Catheterization Kit 16Fr.AMSure® Urethral Self Catheterization Kit 14Fr.AMSure® Urethral Self Catheterization Kit 12Fr.AMSure® Urethral Self Catheterization Kit 10Fr.AMSure® Urethral Self Catheterization Kit 8Fr.AMSure® Pre-Connected Urethral TrayAMSure® Add-A-Foley Catheter Tray

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

FDA product codes

CodeNameDevices
FCMTray, Catheterization, Sterile Urethral, With Or Without Cat36
FCMTray, catheterization, sterile urethral, with or without cat9
KODCatheter, Urological8
GBMCatheter, Urethral6
OHRCatheter care tray4
OHRCatheter Care Tray1

GMDN & GCC registration

  • GMDN code 47778 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 86% · OTC 3%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many intermittent urethral catheterization kit products are registered in the US?

58 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intermittent urethral catheterization kit", from 7 companies. The largest labeler is Amsino International, Inc. with 60% of records.

Which FDA product codes apply?

FCM (Tray, Catheterization, Sterile Urethral, With Or Without Cat), FCM (Tray, catheterization, sterile urethral, with or without cat), KOD (Catheter, Urological), GBM (Catheter, Urethral)

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.

How do I get quotes?

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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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