Device Explorer · FDA GUDID · GMDN 37482

Pleural catheter

A tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after

US‑registered devices426in commercial distribution
Companies18labelers on GUDID
Single‑use100%of device records
Sterile95%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Axiom Medical, Incorporated14233%
Teleflex Incorporated6515%
Cook Incorporated4110%
Fortune Medical Instrument Corp.317%
Armm Inc.287%
Boston Scientific Corporation287%
Atrium Medical Corporation235%
North American Rescue, Llc215%

Top labelers

CompanyDevicesShare
Axiom Medical, Incorporated14233%
Teleflex Incorporated6515%
Cook Incorporated4110%
Fortune Medical Instrument Corp.317%
Armm Inc.287%
Boston Scientific Corporation287%
Atrium Medical Corporation235%
North American Rescue, Llc215%
Diversatek Healthcare, Inc.143%
Redax Spa143%
Clearflow, Inc.102%
Safeguard Us Operating, Llc31%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RocketASEPTPLEUR-EVACVYGONSAM MedicalQT Chest Tube KitPleuraflow® System with FlowGlidePleuraFlow® System with FlowGlideNARNAR KitWayneCookRichliIntro TipTurnerPeters

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

FDA product codes

CodeNameDevices
GBSCatheter, Ventricular, General & Plastic Surgery128
GBXCATHETER, IRRIGATION78
JOLCatheter And Tip, Suction61
KGZAccessories, Catheter49
JOLCATHETER AND TIP, SUCTION31
GBZCatheter, Cholangiography30

GMDN & GCC registration

  • GMDN code 37482 · non‑implantable
  • Single‑use 100% · sterile 95% · Rx‑only 88% · 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

Length (Inch) · 83Catheter Gauge (French) · 71Outer Diameter (Millimeter) · 7

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

No closely related category with 50+ devices.

How many pleural catheter products are registered in the US?

426 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pleural catheter", from 18 companies. The largest labeler is Axiom Medical, Incorporated with 33% of records.

Which FDA product codes apply?

GBS (Catheter, Ventricular, General & Plastic Surgery), GBX (CATHETER, IRRIGATION), JOL (Catheter And Tip, Suction), KGZ (Accessories, Catheter)

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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