Consulting Wallah › Device Explorer › Catheters & tubes › Umbilical catheter
Device Explorer · FDA GUDID · GMDN 10759

Umbilical catheter

A very thin flexible tube designed for umbilical blood vessel access in neonates, typically for the infusion of fluids. It is used mainly in arterial catheterization procedures, but venous catheterization is also possible. It will typically have a double or tr

US‑registered devices60in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Vygon2847%
Utah Medical Products, Inc.1322%
Footprint Medical, Inc.1118%
Cardinal Health 200, Llc712%
Bound Tree Medical, Llc12%

Top labelers

CompanyDevicesShare
Vygon2847%
Utah Medical Products, Inc.1322%
Footprint Medical, Inc.1118%
Cardinal Health 200, Llc712%
Bound Tree Medical, Llc12%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VYGONNACuraplexArgyleUMBILI-CATH

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

FDA product codes

CodeNameDevices
FOSCATHETER, UMBILICAL ARTERY43
FOSCatheter, Umbilical Artery24
JOLCATHETER AND TIP, SUCTION1

GMDN & GCC registration

  • GMDN code 10759 · 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

Catheter Gauge (French) · 40Length (Inch) · 15Length (Centimeter) · 13Total Volume (Milliliter) · 4

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

No closely related category with 50+ devices.

How many umbilical catheter products are registered in the US?

60 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Umbilical catheter", from 5 companies. The largest labeler is Vygon with 47% of records.

Which FDA product codes apply?

FOS (CATHETER, UMBILICAL ARTERY), FOS (Catheter, Umbilical Artery), JOL (CATHETER AND TIP, SUCTION)

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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