UNETIXS VASCULAR, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1222117	1222117	UNETIXS VASCULAR, INC.	1	Y	2026-01-01	333 Strawberry Field Rd Suite 11 Warwick RI US 02886

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
42329	1624189823	K904392	MULTILAB 2000	JAF	1991-04-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JAF	1	1991-04-29

GUDID#

Unetixs Vascular - The MultiLab Series 2 LHS is intended for use as a non-invasive diagnostic device by trained medical personnel following physician orders. This device is intended for the detection of obstruction to blood flow in human arteries and veins as an aid for the diagnosis of disease in the peripheral vascular system.
UNETIXS VASCULAR, INC.
2023-02-27
Unetixs Vascular - The MultiLab is intended for use as a non-invasive diagnostic device by trained medical personnel following physician orders. This device is intended for the detection of obstruction to blood flow in human arteries and veins as an aid for the diagnosis of disease in the peripheral vascular system.
UNETIXS VASCULAR, INC.
2023-02-27
Unetixs Vascular - The MultiLab Series 2 2CP is intended for use as a non-invasive diagnostic device by trained medical personnel following physician orders. This device is intended for the detection of obstruction to blood flow in human arteries and veins as an aid for the diagnosis of disease in the peripheral vascular system.
UNETIXS VASCULAR, INC.
2023-02-27
Unetixs Vascular - The Revo is intended for use as a non-invasive diagnostic device by trained medical personnel following physician orders. This device is intended for the detection of obstruction to blood flow in human arteries and veins as an aid for the diagnosis of disease in the peripheral vascular system.
UNETIXS VASCULAR, INC.
2023-02-27