Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023313463

FEI Number

3023313463

Entity Name

HEARTLAND MANUFACTURING, INC.

City/State/Country

Long Island City, NY, US

Establishment Address

35-35 35th Street, Long Island City, NY 11106, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Heartland Manufacturing, Inc. (Owner Number: 10085626)

Owner / Operator Contact Address

35-35 35th Street, Long Island City, NY 11106, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LEVEL 2 DISPOSABLE ISOLATION GOWN MODEL 27000XL LEVEL 2 DISPOSABLE ISOLATION GOWN MODEL 27000L

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2022-07-12

Official Correspondent

Christina Fumei

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Heartland Manufacturing, Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023313463. Last updated year: 2026. Please use registration number 3023313463 when referencing this establishment in official correspondence.