AeroNOx 2.0 Nitric Oxide Delivery Device 731-9159

GUDID 00865648000337

INTERNATIONAL BIOMEDICAL, LTD.

Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based

• Primary Device ID: 00865648000337
• NIH Device Record Key: e9714642-5940-4ce2-adf9-b02b4d58f56d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroNOx 2.0 Nitric Oxide Delivery Device
• Version Model Number: AeroNOx 2.0
• Catalog Number: 731-9159
• Company DUNS: 073179368
• Company Name: INTERNATIONAL BIOMEDICAL, LTD.
• 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: true
• 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	00865648000337 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193481

FDA Product Code

• MRN: Apparatus, Nitric Oxide Delivery

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: 2021-06-29
• Device Publish Date: 2021-06-21

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