FDA device listing

Passive waste gas scavenger model 14600

FDA device listing 1076046092 · CAREstream Medical LTD

Key facts

Proprietary names Passive waste gas scavenger model 14600
Owner/operator CAREstream Medical LTD
Owner/operator number 10044901
Premarket submissions K080039
Product codes CBN
Device names CBN - Apparatus, Gas-Scavenging
Device class Class II
Classification regulations (21 CFR) 868.5430
Review panels Anesthesiology
Registered establishments CARESTREAM MEDICAL
Establishment registrations 3010396502
FEI numbers 3010396502
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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

Browse all FDA device listings