SSO2 Catheter

Primary DI
20862478000449
Brand
SSO2 Catheter
Company
THEROX, INC.
Model
SSO2 - 3.5
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
10862478000442PackageGS11In Commercial Distribution
20862478000449PackageGS15In Commercial Distribution
00862478000445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086247800044210862478000442
2086247800044920862478000449
00862478000445008624780004458624780004450862478000445

GMDN Terms#

Term, Definition table
TermDefinition
Supersaturated oxygen therapy system catheterA sterile, long and thin flexible tube inserted percutaneously into the vasculature and connected to a supersaturated oxygen (SSO2) therapy system for the infusion of autologous blood mixed with an SSO2 solution (producing oxygen-enriched hyperoxaemic blood) to a targeted coronary artery. It is typically an over-the-wire (OTW) catheter with a radiopaque marker band for fluoroscopic visualization. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
false
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
10862478000428DownStream CartridgeDSC-22019-08-08
20862478000432SSO2 CatheterSSO2 - 4.02019-08-08
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
10862478000428DownStream CartridgeTHEROX, INC.MWG2019-08-08
20862478000432SSO2 CatheterTHEROX, INC.MWG2019-08-08
20862478000456SSO2 CatheterTHEROX, INC.MWG2019-08-08
20862478000463SSO2 CatheterTHEROX, INC.MWG2019-08-08