DownStream System

Primary DI
00862478000414
Brand
DownStream System
Company
THEROX, INC.
Model
DS-1
Device description
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfusedby the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stentingthat 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.
Published
2019-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWGSystem, Oxygen, Aqueous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWGSystem, Oxygen, AqueousUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P170027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170027000TherOx Downstream SystemZoll Circulation, Inc.2019-04-02MWG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862478000414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862478000414008624780004148624780004140862478000414

GMDN Terms#

Term, Definition table
TermDefinition
Supersaturated oxygen therapy systemAn assembly of devices designed to provide supersaturated oxygen (SSO2) therapy to targeted ischemic regions of a patient's coronary vasculature immediately following revasculization by means of percutaneous coronary intervention (PCI) with stenting. It is typically computer-controlled and consists of pumps, valves, detectors/sensors, clamps, patient/parameter monitors, alarms and an O2 gas source. The system controls a cartridge where a small amount of autologous blood is mixed with SSO2 solution (created by the system) producing oxygen-enriched hyperoxaemic blood which is infused via a dedicated catheter. It can have battery backup for short internal patient transport.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-757-1999customerservice@therox.com

Regulatory Flags#

DUNS number
835420894
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862478000421DownStream CartridgeDSC-22019-08-08
00862478000438SSO2 CatheterSSO2 - 4.02019-08-08
00862478000445SSO2 CatheterSSO2 - 3.52019-08-08
00862478000452SSO2 CatheterSSO2 - 4.52019-08-08
00862478000469SSO2 CatheterSSO2 - 5.02019-08-08
00862478000407DownStream SystemDS-1 (Refurbished)2019-08-08
10862478000428DownStream CartridgeDSC-22019-08-08
20862478000432SSO2 CatheterSSO2 - 4.02019-08-08
20862478000449SSO2 CatheterSSO2 - 3.52019-08-08
20862478000456SSO2 CatheterSSO2 - 4.52019-08-08
20862478000463SSO2 CatheterSSO2 - 5.02019-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00862478000421DownStream CartridgeTHEROX, INC.MWG2019-08-08
00862478000438SSO2 CatheterTHEROX, INC.MWG2019-08-08
00862478000445SSO2 CatheterTHEROX, INC.MWG2019-08-08
00862478000452SSO2 CatheterTHEROX, INC.MWG2019-08-08
00862478000469SSO2 CatheterTHEROX, INC.MWG2019-08-08
00862478000407DownStream SystemTHEROX, INC.MWG2019-08-08
10862478000428DownStream CartridgeTHEROX, INC.MWG2019-08-08
20862478000432SSO2 CatheterTHEROX, INC.MWG2019-08-08
20862478000449SSO2 CatheterTHEROX, INC.MWG2019-08-08
20862478000456SSO2 CatheterTHEROX, INC.MWG2019-08-08
20862478000463SSO2 CatheterTHEROX, INC.MWG2019-08-08