DownStream Cartridge

GUDID 10862478000428

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 cartridge

• Primary Device ID: 10862478000428
• NIH Device Record Key: 06e5bb57-aacd-4d22-a0ec-401f63bf9494
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DownStream Cartridge
• Version Model Number: DSC-2
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862478000421 [Primary]
GS1	10862478000428 [Package]; Contains: 00862478000421; Package: Single pack carton [1 Units]; In Commercial Distribution

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: true

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

Devices Manufactured by THEROX, INC.

• 00862478000407 - DownStream System: 2019-08-16 The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to t
• 00862478000414 - DownStream System: 2019-08-16 The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to t
• 10862478000428 - DownStream Cartridge: 2019-08-16The 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.
• 10862478000428 - DownStream Cartridge: 2019-08-16 The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to t
• 20862478000432 - SSO2 Catheter: 2019-08-16 The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to t
• 20862478000449 - SSO2 Catheter: 2019-08-16 The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to t
• 20862478000456 - SSO2 Catheter: 2019-08-16 The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to t
• 20862478000463 - SSO2 Catheter: 2019-08-16 The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to t