FDA UDI
In Commercial Distribution
🇺🇸 United States
BioFlo Vortex
DI: H787CT80STBDNFVI0
·
Model: CT80STBDNFVI
·
NAVILYST MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BioFlo Vortex
- Primary DI
- H787CT80STBDNFVI0
- Version / Model
- CT80STBDNFVI
- Company Name
- NAVILYST MEDICAL, INC.
- Labeler DUNS
- 809699023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-29
- Public Version
- 1
- Public Version Date
- 2020-06-08
- Public Version Status
- New
- Public Device Record Key
- 1cb9effa-2837-4d62-96da-329d160d908f
Device Description
SmartPort+ Standard Port with Endexo and Vortex Technology
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | General Hospital | 880.5965 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61494 | 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | 15051684016919 | GS1 | ||||
| Primary | H787CT80STBDNFVI0 | HIBCC |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190559 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pressure | 300 | Pound per Square Inch | |
| Catheter Gauge | 8 | French | |
| Outer Diameter | 2.6 | Millimeter | |
| Length | 63 | Centimeter |