Consulting Wallah › Device Explorer › Catheters & tubes › Suprapubic drainage catheter
Device Explorer · FDA GUDID · GMDN 34924

Suprapubic drainage catheter

A flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists

US‑registered devices455in commercial distribution
Companies9labelers on GUDID
Single‑use99%of device records
Sterile100%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Applied Medical Technology, Inc.29064%
C. R. Bard, Inc.6214%
Fortune Medical Instrument Corp.347%
Teleflex Incorporated307%
Cook Incorporated286%
Mediplus Ltd72%
Swan Valley Medical, Incorporated20%
North American Rescue, Llc10%

Top labelers

CompanyDevicesShare
Applied Medical Technology, Inc.29064%
C. R. Bard, Inc.6214%
Fortune Medical Instrument Corp.347%
Teleflex Incorporated307%
Cook Incorporated286%
Mediplus Ltd72%
Swan Valley Medical, Incorporated20%
North American Rescue, Llc10%
Canadian Hospital Specialties Limited10%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

S-Cath™Silicone Supra-Pubic Catheter (Ordinary Balloon)Silicone Supra-Pubic Catheter Puncture Set (InteSilicone Supra-Pubic Catheter Exchange Set (InteSilicone Supra-Pubic Catheter (Integrated BallooSilicone Supra-Pubic Catheter Exchange Set (OrdiRUSCHT-SPeCNARAMT MiniSPC Drainage SetMiniSPC ButtonUltrathaneRutnerCookOnik-CohenStamey

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

FDA product codes

CodeNameDevices
KOBCatheter, Suprapubic (And Accessories)329
KNTTubes, Gastrointestinal (And Accessories)290
FEWCatheter, malecot91
KOBCATHETER, SUPRAPUBIC (AND ACCESSORIES)45
FEXInstrument, Catheter, Punch4
KODCATHETER, UROLOGICAL4

GMDN & GCC registration

  • GMDN code 34924 · non‑implantable
  • Single‑use 99% · sterile 100% · Rx‑only 92% · 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) · 356Length (Centimeter) · 291Length (Inch) · 7

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

How many suprapubic drainage catheter products are registered in the US?

455 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Suprapubic drainage catheter", from 9 companies. The largest labeler is Applied Medical Technology, Inc. with 64% of records.

Which FDA product codes apply?

KOB (Catheter, Suprapubic (And Accessories)), KNT (Tubes, Gastrointestinal (And Accessories)), FEW (Catheter, malecot), KOB (CATHETER, SUPRAPUBIC (AND ACCESSORIES))

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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