FDA Registration
Active
🇺🇸 United States
Quality Packaging Specialists International, LLC
Reg #: 3013445151
·
FEI: 1000208912
·
Expires 2026
Products
15
Proprietary Names
31
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- Quality Packaging Specialists International, LLC
- Registration Number
- 3013445151
- FEI Number
- 1000208912
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2030 U.S. Highway 130
- City
- Burlington
- State
- NJ
- ZIP
- 08016
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190058
Owner / Operator
- Firm Name
- Quality Packaging Specialists International
- Operator Number
- 9067895
- Address
- 2030 U.S. Highway 130, --
- City
- Burlington
- State
- NJ
- Postal Code
- 08016
- Country
- US
- Correspondent
- Sutka Veselinovic
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2025-03-12 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2025-04-03 |
| Tampon, Menstrual, Scented, Scented-Deodorized | HIL | Class 2 | Obstetrics/Gynecology | No | 2023-09-22 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2017-04-25 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2026-03-04 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2016-09-06 |
| Detectors And Removers, Lice, (Including Combs) | LJL | Class 1 | General Hospital | No | 2016-11-14 |
| Cup, Menstrual | HHE | Class 2 | Obstetrics/Gynecology | No | 2018-09-11 |
| Pad, Menstrual, Scented, Scented-Deodorized | HHL | Class 2 | Obstetrics/Gynecology | No | 2007-04-27 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2024-01-12 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2007-04-27 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2015-08-18 |
| Timer, Apgar | LHB | Class 1 | General Hospital | No | 2016-11-14 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2007-04-27 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2025-04-03 |
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
Compak Super Scented
Compak Regular Scented
PANTYSHIELDS
MAXI-PADS
DE1LS/598/C2/1 Gentell Hydrogel Sheet Dressing 60x60mm
DE3LS/598/C2/1 Gentell Hydrogel Sheet Dressing 180mm x125mm Borderless
DE2LS/598/C2/1 Gentell Hydrogel Sheet Dressing 120mm x85mm Borderless
Establishment Types
Repack or Relabel Medical Device