Consulting Wallah › Device Explorer › Other devices › Luer/non-ISO80369-standardized linear connector, s
Device Explorer · FDA GUDID · GMDN 64467

Luer/non-ISO80369-standardized linear connector, single-use

A small, non-powered, noninvasive, tubular, two-way/linear connector with a Luer connection (either lock or slip) at one end and a connection which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) at the other e

US‑registered devices69in commercial distribution
Companies7labelers on GUDID
Single‑use99%of device records
Sterile55%labelled sterile
Prescription94%Rx‑only share
ShareLinkedIn

Share of device records

Novosci Corp.2232%
Cook Incorporated1928%
Applied Medical Technology, Inc.1014%
Bd Switzerland Sàrl1014%
Cardinal Health 200, Llc46%
Vygon23%
Uresil, Llc23%

Top labelers

CompanyDevicesShare
Novosci Corp.2232%
Cook Incorporated1928%
Applied Medical Technology, Inc.1014%
Bd Switzerland Sàrl1014%
Cardinal Health 200, Llc46%
Vygon23%
Uresil, Llc23%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VYGONY-Port Feeding AdapterCOOKCookCheck-FloUniversal Funnel AdapterAspiration and Flush AssemblyBD PhaSeal OptimaBD PhaSealBD PhaSeal™ Optima"CONNECTOR, REDUCER 3/8"" X 1/2"" W/LUER""CONNECTOR, REDUCER 1/4"" X 3/8"" W/LUER""CONNECTOR, REDUCER 3/16"" X 1/4"" W/LUER""CONNECTOR, REDUCER 3/16"" X 1/4"" W/LUER NO CAP"CONNECTOR, REDUCER 3/16 X 1/4"" W/LUER""CONNECTOR, STRAIGHT 1/2"" X 1/2"" W/LUER"

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

FDA product codes

CodeNameDevices
KOCAccessories, Blood Circuit, Hemodialysis15
KGZACCESSORIES, CATHETER11
KNTTubes, Gastrointestinal (And Accessories)10
ONBClosed antineoplastic and hazardous drug reconstitution and 10
KRIAccessory Equipment, Cardiopulmonary Bypass7
GBOCatheter, Nephrostomy, General & Plastic Surgery5

GMDN & GCC registration

  • GMDN code 64467 · non‑implantable
  • Single‑use 99% · sterile 55% · Rx‑only 94% · OTC 6%
  • 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) · 10Total Volume (Milliliter) · 2

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

How many luer/non-iso80369-standardized linear connector, single-use products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Luer/non-ISO80369-standardized linear connector, single-use", from 7 companies. The largest labeler is Novosci Corp. with 32% of records.

Which FDA product codes apply?

KOC (Accessories, Blood Circuit, Hemodialysis), KGZ (ACCESSORIES, CATHETER), KNT (Tubes, Gastrointestinal (And Accessories)), ONB (Closed antineoplastic and hazardous drug reconstitution and )

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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