FDA device listing

Generator, Oxygen, Portable

FDA device listing 2049409393 · PROACTIVE MEDICAL PRODUCTS LLC

Key facts

Owner/operator PROACTIVE MEDICAL PRODUCTS LLC
Owner/operator number 10039097
Premarket submissions K252268
Product codes CAW
Device names CAW - Generator, Oxygen, Portable
Device class Class II
Classification regulations (21 CFR) 868.5440
Review panels Anesthesiology
Registered establishments Proactive Medical Products
Establishment registrations 3009327812
FEI numbers 3009327812
Establishment operations Complaint File Establishment
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

Browse all FDA device listings