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Device Explorer · FDA GUDID · GMDN 65823

Non-ISO80369-3-standardized oral syringe, single-use

A manual device consisting of a calibrated hollow barrel (cylinder) and a moveable plunger intended for the administration of oral medication. The tip is not formatted according to the standard for small-bore connectors for enteral applications (ISO 80369-3) [

US‑registered devices72in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile28%labelled sterile
Prescription74%Rx‑only share
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Share of device records

Medsafety Solutions Llc3143%
Mhc Medical Products, Llc1419%
International Medical Industries Inc.912%
Becton, Dickinson And Company811%
B. Braun Medical Inc.46%
Sol-Millennium Medical, Inc.23%
Health Care Logistics, Inc.23%
Medela Llc11%

Top labelers

CompanyDevicesShare
Medsafety Solutions Llc3143%
Mhc Medical Products, Llc1419%
International Medical Industries Inc.912%
Becton, Dickinson And Company811%
B. Braun Medical Inc.46%
Sol-Millennium Medical, Inc.23%
Health Care Logistics, Inc.23%
Medela Llc11%
Cardinal Health 200, Llc11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Exadoral®KwikDose Oral DispenserKwikDose Oral Dispenser Cap10ml Oral Syringe AmberSOL-M 10ml Oral Dispensing Syringe Clear w/Tip CEasyTouchEnteral FeedingTamper Evident Cap for NeoMed Oral DispensersOral Tamper Evident CapBD Oral SyringeHealth Care Logistics, Inc®Kangaroo

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

FDA product codes

CodeNameDevices
KYXDispenser, Liquid Medication60
KYWCONTAINER, LIQUID MEDICATION, GRADUATED8
KYXDISPENSER, LIQUID MEDICATION4
FMFSyringe, Piston3
PRMEnteral administration kit (adult & pediatric)1

GMDN & GCC registration

  • GMDN code 65823 · non‑implantable
  • Single‑use 100% · sterile 28% · Rx‑only 74% · OTC 22%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 38

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

No closely related category with 50+ devices.

How many non-iso80369-3-standardized oral syringe, single-use products are registered in the US?

72 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-ISO80369-3-standardized oral syringe, single-use", from 9 companies. The largest labeler is Medsafety Solutions Llc with 43% of records.

Which FDA product codes apply?

KYX (Dispenser, Liquid Medication), KYW (CONTAINER, LIQUID MEDICATION, GRADUATED), KYX (DISPENSER, LIQUID MEDICATION), FMF (Syringe, Piston)

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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