Oceanic Medical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Oceanic Medical Products, Inc. makes
Oceanic Medical Products, Inc. manufactures anesthesia machines, including the MAGELLAN-2200 (Models 1, 2, and 3) and standalone ventilators under the MAGELLAN brand. These devices are designed for use in surgical and critical care settings to deliver controlled oxygen, gases, and ventilation during procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. These devices are listed in the FDA’s regulatory database and are intended for commercial distribution in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Magellan-2200, Model 1 Ref K010613
Regimes: 510(k) Registry: 510(k)Magellan Ventilator Ref K002951
Regimes: 510(k) Registry: 510(k)Magellan-2200, Model-3 Anesthesia Machine Ref K072420
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 796816515
Frequently asked questions
How many devices does Oceanic Medical Products, Inc. have in the registry?
The registry currently lists 10 devices for Oceanic Medical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oceanic Medical Products, Inc.'s devices?
Among its 10 most recently registered devices, Oceanic Medical Products, Inc. has devices listed in FDA 510(k) (4 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Oceanic Medical Products, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Oceanic Medical Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oceanic Medical Products, Inc. in the registry?
The most recently registered devices listed for Oceanic Medical Products, Inc. include Magellan 2200 Model - 2 1, Magellan Ventilator 1, Magellan 2200 Model - 3 1 and Magellan 2200 Model - 1.