Device Explorer · FDA GUDID · GMDN 35419

Gastrostomy tube

A thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g.,

US‑registered devices924in commercial distribution
Companies17labelers on GUDID
Single‑use96%of device records
Sterile85%labelled sterile
Prescription67%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Avanos Medical, Inc.41945%
Applied Medical Technology, Inc.11412%
Corpak Medsystems, Inc.849%
Cardinal Health, Inc.799%
Xeridiem Medical Devices, Inc.546%
Cook Incorporated404%
Cardinal Health 200, Llc313%
Cutting Edge Hc Brands Llc263%

Top labelers

CompanyDevicesShare
Avanos Medical, Inc.41945%
Applied Medical Technology, Inc.11412%
Corpak Medsystems, Inc.849%
Cardinal Health, Inc.799%
Xeridiem Medical Devices, Inc.546%
Cook Incorporated404%
Cardinal Health 200, Llc313%
Cutting Edge Hc Brands Llc263%
Degania Silicone Ltd212%
Boston Scientific Corporation162%
Dynarex Corporation142%
Medline Industries, Inc.121%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AQUARIUSAquariusMossCapsule Monarch® G-TubeBalloon G-TubeCapsule Dome G-TubeDecompression TubeAMT Balloon G-TubeAMT Capsule Dome G-TubeAMT Capsule Monarch® G-TubeCapsule Monarch® Gastrostomy TubeAMT GuidewireEntuit Gastrostomy BR Balloon Retention Feeding Entuit ThriveCarey Alzate CoonsFlow 20

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

FDA product codes

CodeNameDevices
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)499
KNTTubes, Gastrointestinal (And Accessories)310
KNTTubes, gastrointestinal (and accessories)266
PIFGastrointestinal Tubes With Enteral Specific Connectors80
PIFGastrointestinal Tubes with Enteral Specific Connectors39
KGCTUBE, GASTRO-ENTEROSTOMY35

GMDN & GCC registration

  • GMDN code 35419 · implantable
  • Single‑use 96% · sterile 85% · Rx‑only 67% · 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) · 527Length (Centimeter) · 181Total Volume (Milliliter) · 89Length (Inch) · 11

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

How many gastrostomy tube products are registered in the US?

924 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gastrostomy tube", from 17 companies. The largest labeler is Avanos Medical, Inc. with 45% of records.

Which FDA product codes apply?

KNT (TUBES, GASTROINTESTINAL (AND ACCESSORIES)), KNT (Tubes, Gastrointestinal (And Accessories)), KNT (Tubes, gastrointestinal (and accessories)), PIF (Gastrointestinal Tubes With Enteral Specific Connectors)

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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