AccessGUDID - DEVICE: SSO2 Catheter (00862478000469)

GUDID

Device Identifier (DI) Information

Brand Name: SSO2 Catheter
Version or Model: SSO2 - 5.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THEROX, INC.

Primary DI Number: 00862478000469
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835420894 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47794	Supersaturated oxygen therapy system catheter	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWG	System, Oxygen, Aqueous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P170027	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5F

Device Record Status

Public Device Record Key: ad9cb2ae-05f1-4682-a2b8-dc21b1a4c059
Public Version Date: August 16, 2019
Public Version Number: 1
DI Record Publish Date: August 08, 2019