BONSAI MODEL 800

GUDID 00814470020235

INOVO, INC.

Oxygen cylinder regulator

• Primary Device ID: 00814470020235
• NIH Device Record Key: 372ef3cb-0e22-4fae-86c5-e733c46cb4a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONSAI MODEL 800
• Version Model Number: OM-810
• 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	00814470020235 [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: 2016-11-11

On-Brand Devices [BONSAI MODEL 800]

• 00814470020235: OM-810
• 00814470020204: OM-824