Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043650423

FEI Number

3043650423

Entity Name

HAI SOLUTIONS INC

City/State/Country

Carlsbad, CA, US

Establishment Address

1902 Wright Pl Ste 200, Carlsbad, CA 92008, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

HAI Solutions Inc (Owner Number: 10095256)

Owner / Operator Contact Address

1902 Wright Place, Suite 200, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN250004

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SGX	Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves	General Hospital	Class 2	880.6512	2026-02-12

Official Correspondent

Paul Swaney

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HAI Solutions Inc

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043650423. Last updated year: 2026. Please use registration number 3043650423 when referencing this establishment in official correspondence.