MaxO2Vent

GUDID 00864604000312

OCEANIC MEDICAL PRODUCTS, INC.

Portable pneumatic ventilator

• Primary Device ID: 00864604000312
• NIH Device Record Key: 1ff41216-9ab9-4fa0-9770-6c06cc081fb3
• Commercial Distribution Discontinuation: 2019-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MaxO2Vent
• Version Model Number: 1
• Company DUNS: 796816515
• Company Name: OCEANIC MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864604000312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002951

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-22
• Device Publish Date: 2016-10-21

Devices Manufactured by OCEANIC MEDICAL PRODUCTS, INC.

• 00864604000305 - Magellan Ventilator: 2019-11-22
• 00864604000312 - MaxO2Vent: 2019-11-22
• 00864604000312 - MaxO2Vent: 2019-11-22
• 00864604000329 - Magellan 2200 Model - 1: 2019-11-22
• 00864604000336 - Magellan 2200 Model - 2: 2019-11-22
• 00864604000343 - Magellan 2200 Model - 3: 2019-11-22
• 00864604000367 - Magellan 2200 Model - 3: 2019-11-22