DownStream System

GUDID 00862478000414

The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.

THEROX, INC.

Supersaturated oxygen therapy system

• Primary Device ID: 00862478000414
• NIH Device Record Key: 3f83fd97-0d86-47c7-9765-983b580f4a47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DownStream System
• Version Model Number: DS-1
• Company DUNS: 835420894
• Company Name: THEROX, 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

Customer Support Contacts

• Phone: 949-757-1999
• Email: customerservice@therox.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862478000414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170027

FDA Product Code

• MWG: System, Oxygen, Aqueous

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: 2019-08-16
• Device Publish Date: 2019-08-08

On-Brand Devices [DownStream System]

• 00862478000414: The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Ox
• 00862478000407: The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Ox