Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1932355

FEI Number

1000119270

Entity Name

PRIMUS STERILIZER COMPANY, LLC.

City/State/Country

Great Bend, KS, US

Establishment Address

175 N US HWY 281, Great Bend, KS 67530, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Primus (Owner Number: 9005293)

Owner / Operator Contact Address

110 Tech Dr, Sanford, FL 32771, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221474

PMA Number

N/A

All Registered Proprietary Names

Primus Sterilizer PSS11-HA Primus Sterilizer PSS11-HB one three Sterilizer,steam

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2023-12-20
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2019-02-25
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2007-10-10
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2023-11-03

Official Correspondent

Subramanian Hariharan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Primus

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3030597797	PRIMUS Sterilizer Company LLC	Sanford, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1932355. Last updated year: 2026. Please use registration number 1932355 when referencing this establishment in official correspondence.