OXYMIZER

GUDID 10814470020126

INOVO, INC.

Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator Oxygen therapy conserving regulator 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