AccessGUDID - DEVICE: DownStream System (00862478000414)

GUDID

Device Identifier (DI) Information

Brand Name: DownStream System
Version or Model: DS-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THEROX, INC.

Primary DI Number: 00862478000414
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:	No
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?
47792	Supersaturated oxygen therapy system	An 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.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -18 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3f83fd97-0d86-47c7-9765-983b580f4a47
Public Version Date: August 16, 2019
Public Version Number: 1
DI Record Publish Date: August 08, 2019