BONSAI

GUDID 00814470020037

INOVO, INC.

Oxygen cylinder regulator

• Primary Device ID: 00814470020037
• NIH Device Record Key: 2fabdff2-cb57-4205-b961-f04e1a98d3f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONSAI
• Version Model Number: OM-812
• 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	00814470020037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070740

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: 2016-06-28

On-Brand Devices [BONSAI ]

• 00814470020358: INT-812 CONSERVER WITH D OXYGEN CYLINDER
• 00814470020327: OM-812CE
• 00814470020273: INT-812 CONSERVER WITH ML6 OXYGEN CYLINDER
• 00814470020266: INT-812 CONSERVER WITH M9 OXYGEN CYLINDER
• 00814470020242: INT-812 CONSERVER WITH M6 OXYGEN CYLINDER
• 00814470020037: OM-812
• 00814470020297: Bonsai Pneumatic Oxygen Conserver CE Mark
• 00822383504322: Bonsai Velocity Conserver