Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222117

FEI Number

1222117

Entity Name

UNETIXS VASCULAR, INC.

City/State/Country

Warwick, RI, US

Establishment Address

333 Strawberry Field Rd, Suite 11, Warwick, RI 02886, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

UNETIXS VASCULAR, INC. (Owner Number: 9000359)

Owner / Operator Contact Address

333 Strawberry Field Rd, Suite 11, Warwick, RI 02886, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K904392

PMA Number

N/A

All Registered Proprietary Names

Miltilab Series 2 LHS-TI MultiLab 2000 Series II Revo w/cart Multilab 2000 Series 2 LHS MultiLab 2000 Series II 2CP-R MultiLab 2000 Series II Roodra REVO 1100 MultiLab 2000 Series II LHS-TI Multilab Series 2 LHS ERGO MultiLab 2000 Series II 2CP-R Express Multilab 2000 Series 2-CP-R, Multilab Series 2-CP-R MultiLab 2000 Series II LHS-TI w/Ergo IDC MultiLab 2000 Series 2 Roodra

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	Class 2	892.1540	2008-04-14

Official Correspondent

JOHN HAEFELE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UNETIXS VASCULAR, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010521	Nicolet Biomedical	NICOLET VERSALAB	2001-03-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222117. Last updated year: 2026. Please use registration number 1222117 when referencing this establishment in official correspondence.