Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030243919

FEI Number

3030243919

Entity Name

THE MONARCH COMPANY, LLC

City/State/Country

Birmingham, AL, US

Establishment Address

2700 Corporate Dr Ste 200, Birmingham, AL 35242, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

The Monarch company, LLC (Owner Number: 10089652)

Owner / Operator Contact Address

2700 Corporate Drive Ste 200, Birmingham, AL 35242, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

The Monarch safety Blood Collection Set Monarch Safety Blood Collection set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-12-26
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2024-01-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Monarch company, 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
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Similar Registrations

Registration Number	Establishment Name	Location
3024537844	AVIA VASCULAR	Salt Lake City, UT, US
3006285950	Labcorp CLS	Indianapolis, IN, US
1036836	Sterigenics U.S., LLC	Haw River, NC, US
3030626857	PALM MEDICAL INTERNATIONAL BV	Buggenhout Oost-Vlaanderen, BE
1423507	CAREFUSION 2200, INC.	Vernon Hills, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030243919. Last updated year: 2026. Please use registration number 3030243919 when referencing this establishment in official correspondence.