FDA UDI
In Commercial Distribution
🇺🇸 United States
DownStream System
DI: 00862478000407
·
Model: DS-1 (Refurbished)
·
THEROX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DownStream System
- Primary DI
- 00862478000407
- Version / Model
- DS-1 (Refurbished)
- Company Name
- THEROX, INC.
- Labeler DUNS
- 835420894
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-08
- Public Version
- 1
- Public Version Date
- 2019-08-16
- Public Version Status
- New
- Public Device Record Key
- 3f225e32-37ec-48f0-9679-38b005c924cc
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MWG | System, Oxygen, Aqueous | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862478000407 | GS1 |
Customer Contacts
- Phone
- 949-757-1999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P170027 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 millibar
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius