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Device Explorer · FDA GUDID · GMDN 46629

Temperature-monitoring indwelling urethral drainage catheter

A sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring

US‑registered devices86in commercial distribution
Companies7labelers on GUDID
Single‑use99%of device records
Sterile95%labelled sterile
Prescription57%Rx‑only share
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Share of device records

Deroyal Industries, Inc.2630%
Medline Industries, Inc.1720%
Well Lead Medical Co.,Ltd1619%
Degania Silicone Ltd1214%
Hr Pharmaceuticals Inc.67%
Sewoon Medical Co., Ltd.67%
C. R. Bard, Inc.33%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.2630%
Medline Industries, Inc.1720%
Well Lead Medical Co.,Ltd1619%
Degania Silicone Ltd1214%
Hr Pharmaceuticals Inc.67%
Sewoon Medical Co., Ltd.67%
C. R. Bard, Inc.33%

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

Brand names on the register (sample)

Covidien AGAll Silicone Foley Catheter with Temperature SenTruCathBardex® Lubricath® Temperature-Sensing Foley CatDeRoyalMedlineMEDLINE INDUSTRIES, INC.MEDLINETEMPERATURE SENSING FOLEY BALLOON CATHETER

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

FDA product codes

CodeNameDevices
EZLCatheter, Retention Type, Balloon34
EYCCATHETER, UPPER URINARY TRACT29
EZLCATHETER, RETENTION TYPE, BALLOON12
OHRCatheter care tray10
EZCCATHETER, COUDE3
EXYUROFLOWMETER1

GMDN & GCC registration

  • GMDN code 46629 · non‑implantable
  • Single‑use 99% · sterile 95% · Rx‑only 57% · 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) · 8Length (Millimeter) · 3Total Volume (Milliliter) · 1

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

No closely related category with 50+ devices.

How many temperature-monitoring indwelling urethral drainage catheter products are registered in the US?

86 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Temperature-monitoring indwelling urethral drainage catheter", from 7 companies. The largest labeler is Deroyal Industries, Inc. with 30% of records.

Which FDA product codes apply?

EZL (Catheter, Retention Type, Balloon), EYC (CATHETER, UPPER URINARY TRACT), EZL (CATHETER, RETENTION TYPE, BALLOON), OHR (Catheter care tray)

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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