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Device Explorer · FDA GUDID · GMDN 16616

Medicine bottle

An empty glass or plastic container, typically with a relatively narrow neck and a lid/cap, intended to be used to store medication so that it retains its viability. This is typically a single-patient device that is reused until the contents are exhausted.

US‑registered devices62in commercial distribution
Companies6labelers on GUDID
Single‑use79%of device records
Sterile73%labelled sterile
Prescription5%Rx‑only share
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Share of device records

Cardinal Health 200, Llc4471%
Cardinal Health, Inc.915%
Health Care Logistics, Inc.46%
Fentex Medical Gmbh23%
Rxguardian Inc.23%
Dentsply International Inc.12%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc4471%
Cardinal Health, Inc.915%
Health Care Logistics, Inc.46%
Fentex Medical Gmbh23%
Rxguardian Inc.23%
Dentsply International Inc.12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FENTEXSafer LockDENTSPLY TruByte® Characterized Lucitone® DenturChemoPlusHealth Care Logistics, Inc®

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

FDA product codes

CodeNameDevices
KPECONTAINER, I.V.98
KYXDispenser, Liquid Medication4
LRCINSTRUMENT, ENT MANUAL SURGICAL2
NXBDispenser, solid medication2
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING1

GMDN & GCC registration

  • GMDN code 16616 · non‑implantable
  • Single‑use 79% · sterile 73% · Rx‑only 5% · OTC 89%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 39Weight (Gram) · 1Total Volume (Milliliter) · 1

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

How many medicine bottle products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medicine bottle", from 6 companies. The largest labeler is Cardinal Health 200, Llc with 71% of records.

Which FDA product codes apply?

KPE (CONTAINER, I.V.), KYX (Dispenser, Liquid Medication), LRC (INSTRUMENT, ENT MANUAL SURGICAL), NXB (Dispenser, solid medication)

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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