Consulting Wallah › Device Explorer › Catheters & tubes › Mediastinal drainage catheter, non-antimicrobial
Device Explorer · FDA GUDID · GMDN 32544

Mediastinal drainage catheter, non-antimicrobial

A tube designed to establish a channel for the removal of fluid or purulent material from the mediastinum (the central compartment of the thoracic cavity); it is not coated with an antimicrobial agent. It is typically used in conjunction with, or as a componen

US‑registered devices68in commercial distribution
Companies8labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Axiom Medical, Incorporated2232%
Armm Inc.1826%
Livanova Usa, Inc.1624%
Boston Scientific Corporation46%
Utah Medical Products, Inc.34%
Centese, Inc.23%
Clearflow, Inc.23%
Guangzhou Xinbo Electronic Co., Ltd.11%

Top labelers

CompanyDevicesShare
Axiom Medical, Incorporated2232%
Armm Inc.1826%
Livanova Usa, Inc.1624%
Boston Scientific Corporation46%
Utah Medical Products, Inc.34%
Centese, Inc.23%
Clearflow, Inc.23%
Guangzhou Xinbo Electronic Co., Ltd.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DR -HOSThoraguardPleuraFlow® System with FlowGlideThoracic DrainMedDrainAxiom® High CapacityAxiom® Atraum™ With ClotStop®Axiom®THORA-CATHFlexima™ APDLFlexima™ APD™

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

FDA product codes

CodeNameDevices
KGZAccessories, Catheter18
GBSCATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY16
JOLCatheter And Tip, Suction14
GBSCatheter, Ventricular, General & Plastic Surgery11
FFATUBE, DRAINAGE, SUPRAPUBIC4
GBXCatheter, Irrigation3

GMDN & GCC registration

  • GMDN code 32544 · implantable
  • Single‑use 99% · sterile 99% · Rx‑only 99% · 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) · 7Lumen/Inner Diameter (Millimeter) · 1

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

How many mediastinal drainage catheter, non-antimicrobial products are registered in the US?

68 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mediastinal drainage catheter, non-antimicrobial", from 8 companies. The largest labeler is Axiom Medical, Incorporated with 32% of records.

Which FDA product codes apply?

KGZ (Accessories, Catheter), GBS (CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY), JOL (Catheter And Tip, Suction), GBS (Catheter, Ventricular, General & Plastic Surgery)

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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