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Device Explorer · FDA GUDID · GMDN 36125

Urine-sampling urethral catheter

A sterile flexible tube inserted into the bladder, via the urethra, to obtain a sample of urine that has not been contaminated by urethral passage. The distal end can have various tip designs, and the proximal end may terminate in a soft connecting piece to co

US‑registered devices82in commercial distribution
Companies3labelers on GUDID
Single‑use98%of device records
Sterile100%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Hr Pharmaceuticals Inc.6276%
Flexicare Medical Limited1923%
Becton, Dickinson And Company11%

Top labelers

CompanyDevicesShare
Hr Pharmaceuticals Inc.6276%
Flexicare Medical Limited1923%
Becton, Dickinson And Company11%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PAEDIATRIC PLAIN INTERMITTENT CATHETER STRAIGHT PAEDIATRIC PLAIN INTERMITTENT CATHETER STRAIGHT FEMALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP FEMALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP FEMALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP FEMALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP MALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 10MALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 12MALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 14MALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 16MALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 18MALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 20MALE PLAIN INTERMITTENT CATHETER COUDE TIP 8CHMALE PLAIN INTERMITTENT CATHETER COUDE TIP 10CHMALE PLAIN INTERMITTENT CATHETER COUDE TIP 12CHMALE PLAIN INTERMITTENT CATHETER COUDE TIP 14CH

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

FDA product codes

CodeNameDevices
GBMCATHETER, URETHRAL74
KODCatheter, Urological19
EZDCATHETER, STRAIGHT16
FEZCATHETER AND TUBE, SUPRAPUBIC1

GMDN & GCC registration

  • GMDN code 36125 · non‑implantable
  • Single‑use 98% · sterile 100% · Rx‑only 77% · OTC 5%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 28Catheter Gauge (French) · 28Length (Centimeter) · 28

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

No closely related category with 50+ devices.

How many urine-sampling urethral catheter products are registered in the US?

82 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urine-sampling urethral catheter", from 3 companies. The largest labeler is Hr Pharmaceuticals Inc. with 76% of records.

Which FDA product codes apply?

GBM (CATHETER, URETHRAL), KOD (Catheter, Urological), EZD (CATHETER, STRAIGHT), FEZ (CATHETER AND TUBE, SUPRAPUBIC)

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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