BioFlo
- Primary DI
- 15051684018692
- Brand
- BioFlo
- Company
- Angiodynamics, Inc.
- Model
- 44015
- Device description
- BioFlo Titanium Port with Non Filled Suture Holes and 6F x 63cm Polyurethane Catheter with ENDEXO Technology
- Published
- 2024-09-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | General Hospital | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K131694 | 000 | NMI PORT II CATHETER | Navilyst Medical, Inc. | 2013-08-08 | LJT |
| K153228 | 000 | NMI Port, NMI Port II | Navilyst Medical, Inc. | 2015-12-04 | LJT |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| H965440150 | Previous | HIBCC | 0 | |
| 15051684018692 | Primary | GS1 | 0 | |
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 | Unit |
|---|
| Catheter Gauge | 6 | French |
| Length | 63 | Centimeter |
| Lumen/Inner Diameter | 1.3 | Millimeter |
| Outer Diameter | 2.1 | Millimeter |
Contacts
| Phone | Email |
|---|
| +1(800)772-6446 | customerservice@angiodynamics.com |
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
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