FDA device listing

Specimen Container

FDA device listing 1254456584 · Arrow International LLC (subsidiary of Teleflex Incorporated

Key facts

Proprietary names Specimen Container
Owner/operator Arrow International LLC (subsidiary of Teleflex Incorporated
Owner/operator number 2518433
Product codes KYX
Device names KYX - Dispenser, Liquid Medication
Device class Class I
Classification regulations (21 CFR) 880.6430
Review panels General Hospital
Registered establishments Arrow Internacional de Chihuahua S.A. de C.V.
Establishment registrations 9680794
FEI numbers 3003737899
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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