SMARTDOSE

GUDID 00814470020075

INOVO, INC.

Oxygen cylinder regulator Oxygen cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator Non-fixed medical gas cylinder regulator

• Primary Device ID: 00814470020075
• NIH Device Record Key: 5854e7cd-c5d2-404e-9dd2-ec8164c7768b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTDOSE
• Version Model Number: CTOX-MN02
• 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	00814470020075 [Primary]
GS1	50822383296406 [Package]; Package: Master Carton [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090421

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-28

Devices Manufactured by INOVO, INC.

• 00822383504322 - BONSAI: 2023-10-24 Bonsai Velocity Conserver
• 50822383018558 - EVOLUTION: 2023-06-02 EVOLUTION 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
• 00814470020075 - SMARTDOSE: 2018-07-06
• 00814470020075 - SMARTDOSE: 2018-07-06