Evolution™

GUDID 50822383515552

Evolution™ Electronic Oxygen Conserver

INOVO, INC.

Non-fixed medical gas cylinder regulator

• Primary Device ID: 50822383515552
• NIH Device Record Key: 06244590-d173-4a34-b578-db03ded90749
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolution™
• Version Model Number: OM-924
• 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	00822383515557 [Primary]
GS1	50822383515552 [Package]; Contains: 00822383515557; 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: 2023-06-02
• Device Publish Date: 2023-05-25

Devices Manufactured by INOVO, INC.

• 50822383024870 - SmartDose Evolution: 2024-11-15 SmartDose Evolution Electronic Conserver
• 00822383504322 - BONSAI: 2023-10-24 Bonsai Velocity Conserver
• 50822383018558 - EVOLUTION: 2023-06-02 EVOLUTION ELECTRONIC OXYGEN CONSERVER
• 50822383515552 - Evolution™: 2023-06-02Evolution™ Electronic Oxygen Conserver
• 50822383515552 - Evolution™: 2023-06-02 Evolution™ Electronic Oxygen Conserver
• 00822383018522 - EVOLUTION: 2023-05-08 EVOLUTION ELECTRONIC OXYGEN CONSERVER
• 00822383018515 - Drive: 2022-09-29 Evolution Electronic Oxygen Conserver
• 00814470020297 - BONSAI: 2021-09-28 Bonsai Pneumatic Oxygen Conserver CE Mark
• 00814470020327 - BONSAI: 2019-02-18