FDA device listing

Generator, Oxygen, Portable

FDA device listing 1522977699 · Seaside Marine International Drug Co., Inc.

Key facts

Owner/operator Seaside Marine International Drug Co., Inc.
Owner/operator number 10049653
Premarket submissions K102750
Product codes CAW
Device names CAW - Generator, Oxygen, Portable
Device class Class II
Classification regulations (21 CFR) 868.5440
Review panels Anesthesiology
Registered establishments SEASIDE MARINE INTERNATIONAL DRUG CO., INC.
Establishment registrations 3011767915
FEI numbers 3011767915
Establishment operations Repackager/Relabeler
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

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