FDA device listing

Filter; Membrane,Membrane filter unit,MiniStop Filter Closed Waste Basin,Unit, Filter, Membrane

FDA device listing 1501038137 · Sotera Health LLC

Key facts

Proprietary names Filter; Membrane,Membrane filter unit,MiniStop Filter Closed Waste Basin,Unit, Filter, Membrane
Owner/operator Sotera Health LLC
Owner/operator number 10029425
Product codes JRL
Device names JRL - Unit, Filter, Membrane
Device class Class I
Classification regulations (21 CFR) 862.2050
Review panels Clinical Chemistry
Registered establishments Sterigenics U.S. LLC, Sterigenics U.S., LLC
Establishment registrations 1036836, 1054811, 1721676, 2029275
FEI numbers 1036836, 1721676, 1000114185, 1000306431
Establishment operations Contract Sterilizer
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

Browse all FDA device listings