EVOLUTION ELECTRONIC OXYGEN CONSERVER

GUDID 00814470020150

INOVO, INC.

Oxygen cylinder regulator

• Primary Device ID: 00814470020150
• NIH Device Record Key: bf8ff4cc-6467-4032-9bdf-76d53861cc9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOLUTION ELECTRONIC OXYGEN CONSERVER
• Version Model Number: OM-900A
• 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	00814470020150 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-25

On-Brand Devices [EVOLUTION ELECTRONIC OXYGEN CONSERVER]

• 00814470020303: OM-903J
• 00814470020228: OM-900CE
• 00814470020198: OM-904J
• 00814470020150: OM-900A
• 00814470020143: OM-900B
• 00814470020136: OM-950
• 00814470020044: OM-900