Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1223924

FEI Number

1000305719

Entity Name

MCNEIL HEALTHCARE LLC

City/State/Country

Fairfield, NJ, US

Establishment Address

311 Rt 46 West, Unit C, Fairfield, NJ 07004, US

Establishment Type(s)

Manufacture Medical Device,Repack or Relabel Medical Device

Owner / Operator

McNeil Healthcare Packaging LLC (Owner Number: 10083742)

Owner / Operator Contact Address

311 Route 46 West, Suite C, Fairfield, NJ 07004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K935911

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
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2022-01-13
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2022-01-13
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2022-01-13
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2022-01-13
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2022-03-24
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2022-01-13
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2022-01-13
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2022-01-13

Official Correspondent

Ann Pieringer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

McNeil Healthcare Packaging LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K861444	Surgical Specialties, Inc.	S1 NASAL PACKING	1986-05-06
K863737	Hermitage Hospital Products, Inc.	SPONGES STERILE TWIN PAKT AND SINGLES	1986-10-14
K940351	Certified Safety Mfg., Inc.	EXTRA LARGE COMPRESS DRESSING	1994-02-25
K950404	Lockett Medical Corp.	LOCKETT MEDICAL CORP. GAUZE	1995-04-17
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

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2242656	VISCOT MEDICAL LLC	EAST HANOVER, NJ, US
1018120	Cardinal Health	AUGUSTA, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1223924. Last updated year: 2026. Please use registration number 1223924 when referencing this establishment in official correspondence.