FDA device listing

Disposable Mouthpiece, Flex V-892893,Disposable Mouthpiece, Flex V-892894,Disposable Mouthpiece, Flex…

FDA device listing 1366661504 · Jaeger Medical GmbH

Key facts

Proprietary names Disposable Mouthpiece, Flex V-892893,Disposable Mouthpiece, Flex V-892894,Disposable Mouthpiece, Flex V-892897,Disposable Mouthpiece, plastic 892103,Disposable Mouthpiece, plastic V-892896
Owner/operator Jaeger Medical GmbH
Owner/operator number 10092652
Product codes BYP
Device names BYP - Mouthpiece, Breathing
Device class Class I
Classification regulations (21 CFR) 868.5620
Review panels Anesthesiology
Registered establishments Jaeger Medical America Inc., Jaeger Medical GmbH
Establishment registrations 9615102, 3033959233
FEI numbers 1000271197, 3033959233
Establishment operations Complaint File Establishment, Repackager/Relabeler, Specification Developer
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