Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004634710

FEI Number

3004634710

Entity Name

Andersen Sterilizers, Inc.

City/State/Country

Haw River, NC, US

Establishment Address

3154 Caroline Dr, Haw River, NC 27258, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Andersen Sterilizers (Owner Number: 10051558)

Owner / Operator Contact Address

3154 Caroline Drive, Haw River, NC 27258, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150644

PMA Number

N/A

All Registered Proprietary Names

Tyvek Sterilization Pouches with Chevron Seal Anprolene SteriTest, AN7508.14 Anprolene Steritest RRBI Sterisheet Sterilization Wrap Anprolene AN75 Ethylene Oxide Sterilizer Sterilization Process Indicator EOGas 4® SteriTest EOGas 4® Ethylene Oxide Gas Sterilizer EOGas 4 Endo-SteriTest Sterisheet Sterilization Wrap AN1087 Dosimeter AN87 Dosimeter EOGas 4 Endo-SteriTest RRBI AN85/AN86 EO Indicators

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2021-12-20
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2017-11-16
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2022-12-08
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2017-11-16
FLF	Sterilizer, Ethylene-Oxide Gas	General Hospital	Class 2	880.6860	2017-11-16
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2021-12-20
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2016-04-04
FLF	Sterilizer, Ethylene-Oxide Gas	General Hospital	Class 2	880.6860	2016-04-04
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2021-12-20
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2021-12-20
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2016-04-04
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2017-11-16
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2021-12-20
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2016-04-04

Official Correspondent

Faith Rios

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Andersen Sterilizers

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
K151482	Bcr Diagnostics, Inc.	BCR-30-min BI and RBIP-ST30 Readout Accessory	2016-02-26
K142034	3M Company	3M STERI-VAC STERILIZER/AERATOR	2015-01-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2013	3M Company Health Care Business 3M Center	2	3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

Similar Registrations

Registration Number	Establishment Name	Location
2523664	M & Q PACKAGING LLC	SCHUYLKILL HAVEN, PA, US
9680031	STEPAC L.A., LTD.	TEFEN, WESTERN GALILEE Northern, IL
9616096	La Ada de Acuna	CIUDAD DE ACUNA Coahuila, MX
1054380	Halyard North Carolina, LLC	LINWOOD, NC, US
8030674	ESPECIALISTAS EN ESTERILIZACION Y ENVASE, S. A. DE C. V.	Tlalnepantla, Estado de Mexico, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004634710. Last updated year: 2026. Please use registration number 3004634710 when referencing this establishment in official correspondence.