EVOLUTION

GUDID 00822383018522

EVOLUTION ELECTRONIC OXYGEN CONSERVER

INOVO, INC.

Non-fixed medical gas cylinder regulator

• Primary Device ID: 00822383018522
• NIH Device Record Key: 43b7e123-eaab-4f2b-92e8-c41d549b79f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOLUTION
• Version Model Number: OM-900CE
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822383018522 [Primary]
GS1	50822383018527 [Package]; Package: Master Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103392

FDA Product Code

• NFB: Conserver, Oxygen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-08
• Device Publish Date: 2023-04-28

On-Brand Devices [EVOLUTION ]

• 00822383018522: EVOLUTION ELECTRONIC OXYGEN CONSERVER
• 50822383018558: EVOLUTION ELECTRONIC OXYGEN CONSERVER