Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015361761

FEI Number

3015361761

Entity Name

PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

City/State/Country

Woodcliff Lake, NJ, US

Establishment Address

400 Chestnut Ridge Road, Woodcliff Lake, NJ 07677, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Professional Disposables International, Inc. (Owner Number: 2411192)

Owner / Operator Contact Address

400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132380

PMA Number

N/A

All Registered Proprietary Names

Hygea Sterile Saline Wipe PREVANTICS DEVICE SWAB PREVANTICS DEVICE SWAB STRIP PREVANTICS DEVICE LARGE SWAB

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2017-07-19
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2014-11-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Professional Disposables International, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2411192	PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.	ORANGEBURG, NY, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015361761. Last updated year: 2026. Please use registration number 3015361761 when referencing this establishment in official correspondence.