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BioFlo Vortex

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name
BioFlo Vortex FDA UDI
Generic Name
Vascular port/catheter FDA UDI
Device Name
SmartPort+ Low Profile with Endexo and Vortex Technology FDA UDI
Model / Reference
CT60LPBAVI FDA UDI
Description
SmartPort+ Low Profile with Endexo and Vortex Technology FDA UDI

Identifiers

Primary DI / UDI-DI
H787CT60LPBAVI0 FDA UDI
510(k) Number
K190559 FDA UDI
FDA Product Code
LJT FDA UDI
GMDN Term
Vascular port/catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5965 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 6 French FDA UDI
Length — 63 Centimeter FDA UDI
Outer Diameter — 2.1 Millimeter FDA UDI

BioFlo Vortex by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K190559 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Navilyst Medical, Inc.

Sources (1)

  • FDA UDI 1a3adca3-d7ed-4d7e-a528-8e408c3ce1e2 37 fields · synced May 31, 2026