Consulting Wallah › Device Explorer › Catheters & tubes › Gastrostomy tube kit, non-medicated
Device Explorer · FDA GUDID · GMDN 64464

Gastrostomy tube kit, non-medicated

A collection of devices which includes a gastrostomy tube and other instruments intended for short- and/or long-term (= 24 hours) access to the stomach via a gastrostomy; it does not include any pharmaceutical agents. In addition to the gastrostomy tube, the k

US‑registered devices97in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Medline Industries, Inc.8992%
Cook Incorporated88%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.8992%
Cook Incorporated88%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EntuitMedline

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

FDA product codes

CodeNameDevices
PSHPercutaneous replacement gastrostomy tube kit89
PRRFeeding tube kit8
KGCTUBE, GASTRO-ENTEROSTOMY8

GMDN & GCC registration

  • GMDN code 64464 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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

No structured size data on the register.

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

How many gastrostomy tube kit, non-medicated products are registered in the US?

97 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gastrostomy tube kit, non-medicated", from 2 companies. The largest labeler is Medline Industries, Inc. with 92% of records.

Which FDA product codes apply?

PSH (Percutaneous replacement gastrostomy tube kit), PRR (Feeding tube kit), KGC (TUBE, GASTRO-ENTEROSTOMY)

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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