Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2150060

FEI Number

2150060

Entity Name

Medivators Inc

City/State/Country

MINNEAPOLIS, MN, US

Establishment Address

14605 28th Avenue North, MINNEAPOLIS, MN 55447, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

STERIS Corporation (Owner Number: 2150060)

Owner / Operator Contact Address

5960 Heisley Rd, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rapicide PA High Level Disinfectant Advantage Plus Endoscope Reprocessing System Hookups for Advantage Plus Endoscope Reprocessing System CER Series Automatic Endoscope Reprocessor (CFE) MV/CLM Automatic Endoscope Reprocessor (CFE) Hookups for CER Series Automatic Endoscope Reprocessor (MF) Electro Lube NXT (PY-CM, KS-SD) Scope Buddy Endoscope Flushing Aid (PY-USMXD) (EFAING) Adaspor Plus Minimum Required Concentration (MRC) Test Strips (78401114) Rapicide PA Ready-To-Use Minimum Required Concentration (MRC) Test Strips ML02-0129 Rapicide High-Level Disinfectant Intercept Detergent WIPES Intercept Detergent Medline Drawstring Pad Wide (101800) Intercept Plus Detergent Single Ended Brush (100401) (CO-CFE) PULL THRU 4.8MM CASSETTE REFILL (180X12) 4002598 INTERCEPT Bedside Kit MICRO PULL THRU CASSETTE REFILL (360X12) 4002607 DOUBLE BALLOON PULL THRU W/ STUBBY COMBO PULL THRU CASSETTE REFILL (240X12) 4002597 MICRO PULL THRU SINGLE (4002604) MINI PULL THRU CASSETTE REFILL (2400X4) 4002602 DOUBLE ENDED STUBBY BRUSH (180) PULL THRU CHANNEL CLEANING BRUSH SINGLE (4002592) MICRO PULL THRU 60PK W/ CASSETTE, MOUNT (4002605) Intercept Foam PULL THRU CASSETTE WALL MOUNT (4002594) Transport Pad (100800) DOUBLE ENDED STUBBY BRUSH SINGLE PULL THRU W/ STUBBY COMBO SINGLE (4002593) MICRO PULL THRU CASSETTE REFILL (180X12) 4002606 MINI PULL THRU CASSETTE REFILL (360X12) (4002603) MINI PULL THRU W/ STUBBY COMBO (4002600) PULL THRU CASSETTE REFILL PACK (180X12) 4002596 PULL THRU 60PK W/ CASSETTE AND MOUNT (4002601) PULL THRU DEMO UNIT (4002612) DOUBLE BALLOON PULL THRU SINGLE MINI PULL THRU 60PK W/ CASSETTE, MOUNT (4002601) MINI PULL THRU SINGLE (4002599) Intercept One Ready-to-Use Bedside Kit Intercept Next-Generation Detergent Bedside Kit Rapicide PA High-Level Disinfectant Test Strips (ML020118) (PY-SD, LC-MF) ENDODRY Storage & Drying System (PM-MF) Tubing Sets for Reliance 6500 Series Endoscope Drying and Storage Cabinet (PY-SD, HP-MF) Rapicide OPA/28 Test Strips (ML02-0137) Rapicide OPA 28 Minimum Required Concentration (MRC) Test Strip (ML02-0136) Scope Buddy Plus Air/Water Blanking Cap (PY-MF) Scope Buddy Plus Endoscope Flushing Aid (PY-MF) Scope Buddy Plus Tubing (CO-MF, PY-SD) Medivators Rapicide Glutaraldeyde Indicator Test Strip- (ML020120) (LC-CM, PY-SD) DSD Edge Endoscope Reprocessing System (DSD-3008) (PY-MF) Hookups for DSD Series Endoscope Reprocessor (PY-MF) Minncare HD Minncare HD Minimum Required Concentration (MRC) Test Strips (3029796) Minncare HD Residual Test Strips (3029795) Advantage Plus Pass-Thru Automated Endoscope Reprocessor Hookups for Advantage Plus Pass-Thru Automated Endoscope Reprocessor Scope Buddy Endoscope Flushing Aid (PY-CFE) Scope Buddy Plus Endoscope Flushing Aid (PY-MF) Scope Buddy Plus Tubing (CO-MF, PY-SD) Rapicide PA Test Strip Advantage Plus Endoscope Reprocessing System Rapicide PA High Level Disinfectant Hookups for Advantage Plus Endoscope Reprocessing System Rapicide PA Ready-to-Use High-Level Disinfectant (4001021) Rapicide HLD Test Strips Rapicide OPA-28 High Level Disinfectant Hookups for DSD Series Endoscope Reprocessor DSD Series Endoscope Reprocessor (PY-CFE) SSD Series Endoscope Reprocessor Renalin 100 Cold Sterilant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2018-01-15
NVE	Washer, Cleaner, Automated, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2008-10-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-28
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2022-11-29
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-04-22
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2008-10-09
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2012-04-18
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2016-03-24
PUP	Endoscope Maintenance System	Gastroenterology, Urology	Class 2	876.1500	2024-04-04
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2016-05-03
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2022-01-22
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2017-06-14
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2010-06-07
NIH	Disinfectant, Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2022-03-20
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2017-12-20
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2017-04-18
FKP	System, Dialysate Delivery, Single Patient	Gastroenterology, Urology	Class 2	876.5820	2021-08-24
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2009-12-21
MSY	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant	Gastroenterology, Urology	Class 2	876.5665	2022-03-14
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2013-01-27
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2008-01-25
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2008-10-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
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
3005646850	Jabil Inc.	AUBURN HILLS, MI, US
9610849	Covidien	TIJUANA, B.C. Mexico, MX
8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP
1527821	STERIS CORPORATION	Mentor, OH, US
1651395	Medivators Inc	Conroe, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2150060. Last updated year: 2026. Please use registration number 2150060 when referencing this establishment in official correspondence.