BioFlo Vortex
- Primary DI
- 15051684016858
- Company
- Angiodynamics, Inc.
- Model
- CT50STBANFVI
- Device description
- SmartPort+ Standard Port with Endexo and Vortex Technology
- Published
- 2024-11-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 079252781
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 15051684016858 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 15051684016858 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 | General Hospital | 880.5965 | Y | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K190559 | 000 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | AngioDynamics, Inc. | 2020-05-22 | LJT |
GMDN Terms
| Term | Definition |
|---|
| Vascular port/catheter | A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included. |
Device Sizes
| Type | Value | Text |
|---|
| Catheter Gauge | 5 French | |
| Length | 45 Centimeter | |
| Outer Diameter | 1.8 Millimeter | |
Storage And Handling
No records found.
Contacts
| Phone | Email |
|---|
| +1(800)772-6446 | customerservice@angiodynamics.com |
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