Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009446098

FEI Number

3009446098

Entity Name

QPSI Mooresville

City/State/Country

Mooresville, IN, US

Establishment Address

9440 South State Route 39, Suite 1, Mooresville, IN 46158, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Quality Packaging Specialists International (Owner Number: 9067895)

Owner / Operator Contact Address

2030 U.S. Highway 130, --, Burlington, NJ 08016, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Band Aid tapes, bandages & adhesive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2020-02-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-04-25

Official Correspondent

Sutka Veselinovic

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Quality Packaging Specialists International

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005010990	QPSI DISPLAY SERVICES LLC	MECHANICSBURG, PA, US
3013445151	Quality Packaging Specialists International, LLC	Burlington, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K093254	Abbott Medical Optics, Inc.	AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION	2010-09-15
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-05	Ciba Vision Corporation	2	SOLO-care Plus with Aqualube, Multi-purpose solution* AquaSoft (Private label), Multi-purpose solutionSterile**For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
Z-0129-2011	Abbott Medical Optics Inc (AMO)	2	AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
Z-0130-2011	Abbott Medical Optics Inc (AMO)	2	AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.

Similar Registrations

Registration Number	Establishment Name	Location
1643525	ALLERGAN SALES, LLC	WACO, TX, US
3003306559	GLOBAL PACKAGING SYSTEMS INC	Fort Worth, TX, US
3012236936	Johnson & Johnson Surgical Vision, Inc.	Irvine, CA, US
9617489	TAIWAN BIOTECH CO., LTD.	TAOYUAN, TW
1032500	Bausch & Lomb Incorporated	GREENVILLE, SC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009446098. Last updated year: 2026. Please use registration number 3009446098 when referencing this establishment in official correspondence.