DownStream Cartridge

Primary DI
10862478000428
Brand
DownStream Cartridge
Company
THEROX, INC.
Model
DSC-2
Device description
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.
Published
2019-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
10862478000428PackageGS11In Commercial Distribution
00862478000421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086247800042810862478000428
00862478000421008624780004218624780004210862478000421

GMDN Terms#

Term, Definition table
TermDefinition
Supersaturated oxygen therapy system cartridgeA sterile, sealed container (cartridge) that is placed into a supersaturated oxygen (SSO2) therapy system for the mixing of autologous blood with an SSO2 solution [typically created in the container with oxygen (O2) and saline], to produce oxygen-enriched hyperoxaemic blood that is delivered (infused) to the patient by means of a dedicated catheter that connects to this cartridge. It is typically made of plastic and silicone materials, has several chambers, and is connected to the system's O2 gas source. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
835420894
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00862478000414DownStream SystemDS-12019-08-08
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
00862478000414DownStream SystemTHEROX, 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