FDA device listing

Lavage, Jet

FDA device listing 1907027910 · Asept Pak Inc.

Key facts

Owner/operator Asept Pak Inc.
Owner/operator number 10024698
Product codes FQH
Device names FQH - Lavage, Jet
Device class Class II
Classification regulations (21 CFR) 880.5475
Review panels General Hospital
Registered establishments ClensTech Inc.dba ASEPT PAK INC.
Establishment registrations 3007177643
FEI numbers 3007177643
Establishment operations Contract Manufacturer, Manufacturer, Repackager/Relabeler
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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