OXYMIZER

GUDID 10814470020126

INOVO, INC.

Oxygen therapy conserving regulator

• Primary Device ID: 10814470020126
• NIH Device Record Key: 8c3f7c63-0b99-4396-8cc9-7d117e7cce54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXYMIZER
• Version Model Number: O-224
• Company DUNS: 015954530
• Company Name: INOVO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814470020129 [Primary]
GS1	10814470020126 [Package]; Contains: 00814470020129; Package: Master Box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830009

FDA Product Code

• NFB: Conserver, Oxygen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-26

On-Brand Devices [OXYMIZER]

• 10814470020256: F-224
• 10814470020126: O-224
• 10814470020119: P-224