Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013445151

FEI Number

1000208912

Entity Name

Quality Packaging Specialists International, LLC

City/State/Country

Burlington, NJ, US

Establishment Address

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

K040312

PMA Number

N/A

All Registered Proprietary Names

Pure Sleep (OTC) Roll Compact Plastic Applicator Organic Cotton Tampon (PAD) - Unicorn Playtex Sport 14ct Super unscented - Edgewell Playtex 8ct Super Sport - Edgwell Playtex Sport Super 8ct 4/12 - Edgewell Band Aid tapes, bandages & adhesive Lansinoh Soothies Relief+ Cooling Gel Nipple Pads TAMPONS PANTYLINE DEODORANT PANTY SH DEODORANT PANTYSHIELDS PANTILINERS DEODORANT MAXI-PADS CONTOURED CONTOURED ABSORBENT SHIELD Compak Super Unscented ULTRA ABSORBENCY SUPER & SUPER PLASTIC APPLICATOR TAM LIGHT SUPER Compak Regular Unscented SCENTED TAMPONS REGULAR SUPER Compak Super Scented Compak Regular Scented

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2025-03-12
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2025-04-03
HIL	Tampon, Menstrual, Scented, Scented-Deodorized	Obstetrics/Gynecology	Class 2	884.5460	2023-09-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-04-25
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2026-03-04
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2007-04-27
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2016-09-06
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	Class 1	880.5960	2016-11-14
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2020-10-23
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2020-10-23
HIL	Tampon, Menstrual, Scented, Scented-Deodorized	Obstetrics/Gynecology	Class 2	884.5460	2020-10-23
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2018-09-11
HHL	Pad, Menstrual, Scented, Scented-Deodorized	Obstetrics/Gynecology	Class 2	884.5425	2007-04-27
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2024-01-12
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2007-04-27
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2007-04-27
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2015-08-18
LHB	Timer, Apgar	General Hospital	Class 1	880.2930	2016-11-14
HIL	Tampon, Menstrual, Scented, Scented-Deodorized	Obstetrics/Gynecology	Class 2	884.5460	2007-04-27

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
3009446098	QPSI Mooresville	Mooresville, IN, US
3005010990	QPSI DISPLAY SERVICES LLC	MECHANICSBURG, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02
K930149	Kimberly-Clark Corp.	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	1994-03-02
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21

Similar Registrations

Registration Number	Establishment Name	Location
3030914478	GELB PRACTICE	Dix Hills, NY, US
3017092365	APNOMED, INC.	Bellevue, WA, US
3039643908	EMA-SLEEP INC	Bastrop, TX, US
3007108578	TRUE FUNCTION LABORATORY INC	La Mesa, CA, US
3006786034	Innovative Health Technologies (NZ) Limited	Dunedin Otago, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013445151. Last updated year: 2026. Please use registration number 3013445151 when referencing this establishment in official correspondence.