FDA UDI
In Commercial Distribution
🇺🇸 United States
SSO2 Catheter
DI: 00862478000445
·
Model: SSO2 - 3.5
·
THEROX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SSO2 Catheter
- Primary DI
- 00862478000445
- Version / Model
- SSO2 - 3.5
- 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
- c4680f49-e7a2-4f00-99bc-d8a74cb01371
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
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20862478000449 | GS1 | Five pack carton | 5 | In Commercial Distribution | |
| Primary | 00862478000445 | GS1 | ||||
| Package | 10862478000442 | GS1 | Single pack carton | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 949-757-1999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P170027 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5F |