FDA device listing

Male Tamper Evident Cap

FDA device listing 1806895156 · International Medical Industries, Inc.

Key facts

Proprietary names Male Tamper Evident Cap
Owner/operator International Medical Industries, Inc.
Owner/operator number 1217831
Premarket submissions K182545
Product codes FMF, FPA
Device names FMF - Syringe, Piston, FPA - Set, Administration, Intravascular
Device class Class II
Classification regulations (21 CFR) 880.5440, 880.5860
Review panels General Hospital
Registered establishments INTL. MEDICAL INDUSTRIES
Establishment registrations 1217831
FEI numbers 1217831
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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