FDA UDI
In Commercial Distribution
🇺🇸 United States
PROTEK SOLO
DI: 08033178019354
·
Model: 5140-6217
·
SORIN GROUP ITALIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROTEK SOLO
- Primary DI
- 08033178019354
- Version / Model
- 5140-6217
- Company Name
- SORIN GROUP ITALIA SRL
- Labeler DUNS
- 442126587
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-14
- Public Version
- 2
- Public Version Date
- 2025-01-23
- Public Version Status
- Update
- Public Device Record Key
- ffbe8f8f-ecba-43be-a5c2-a6b3323ffa60
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46849 | Circulatory assist transseptal cannula | A sterile tubular device designed for cannulation of the left atrium through the atrial septum, via the femoral vein, to drain the atrium and provide a means for temporary (less than six hours) left ventricular bypass [percutaneous transseptal ventricular assist (PTVA)]. It is a semi-rigid device (also known as a transseptal catheter) which may have a curved distal tip to better conform to the anatomy. Once in situ it is connected to an extracorporeal blood pump which returns blood to the patient. Disposable device dedicated to catheter introduction/function (e.g., obturator, dilator) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033178019354 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082425 | 000 |