Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003936696

FEI Number

3003936696

Entity Name

ARC Specialty Products, Balchem Corporation

City/State/Country

Green Pond, SC, US

Establishment Address

95 Balchem Lane, Green Pond, SC 29446, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ARC Specialty Products, Balchem Corporation (Owner Number: 10026195)

Owner / Operator Contact Address

90 Crystal Run Rd., Ste. 202, 90 Crystal Run Rd., Middletown, NY 10941, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
FLF	Sterilizer, Ethylene-Oxide Gas	General Hospital	Class 2	880.6860	2008-09-08
FLF	Sterilizer, Ethylene-Oxide Gas	General Hospital	Class 2	880.6860	2008-09-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARC Specialty Products, Balchem Corporation

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
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.

Similar Registrations

Registration Number	Establishment Name	Location
2084725	ADVANCED STERILIZATION PRODUCTS	Irvine, CA, US
3042272797	SOLVENTUM US LLC	Eagan, MN, US
3015392401	ASP Global Manufacturing GmbH	SCHAFFHAUSEN, CH
2133641	BENCHMARK ELECTRONICS, INC.	WINONA, MN, US
3005646850	Jabil Inc.	AUBURN HILLS, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003936696. Last updated year: 2026. Please use registration number 3003936696 when referencing this establishment in official correspondence.