Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1420088

FEI Number

1420088

Entity Name

IRONWOOD INDUSTRIES, INC.

City/State/Country

LIBERTYVILLE, IL, US

Establishment Address

115 SOUTH BRADLEY RD., LIBERTYVILLE, IL 60048, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IRONWOOD INDUSTRIES, INC. (Owner Number: 1420088)

Owner / Operator Contact Address

28640 N BRADLEY RD., --, Libertyville, IL 60048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Container, IV Snoring Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2021-06-28
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2022-03-22

Official Correspondent

Jason Grala

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IRONWOOD INDUSTRIES, INC.

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
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0003-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0004-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0005-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Similar Registrations

Registration Number	Establishment Name	Location
3004181163	CGR Minnesota LLC	Inver Grove Heights, MN, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1423507	CAREFUSION 2200, INC.	Vernon Hills, IL, US
3000268902	IMPERIAL TRADING LIMITED	Bridgetown Saint Michael, BB
2025816	ICU MEDICAL, INC.	SAN CLEMENTE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1420088. Last updated year: 2026. Please use registration number 1420088 when referencing this establishment in official correspondence.