DownStream System

GUDID 00862478000407

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 ID00862478000407
NIH Device Record Key3f225e32-37ec-48f0-9679-38b005c924cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDownStream System
Version Model NumberDS-1 (Refurbished)
Company DUNS835420894
Company NameTHEROX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-757-1999
Emailcustomerservice@therox.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100862478000407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWGSystem, Oxygen, Aqueous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-16
Device Publish Date2019-08-08

On-Brand Devices [DownStream System]

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

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