BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medivators Inc

    Reg #: 2150060 · FEI: 2150060 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    70
    Establishment Types
    5
    Classifications
    12

    Registration Details

    Registration Name
    Medivators Inc
    Registration Number
    2150060
    FEI Number
    2150060
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    14605 28th Avenue North
    City
    MINNEAPOLIS
    State
    MN
    ZIP
    55447
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102996

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    2150060
    Address
    5960 Heisley Rd
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Accessories, Cleaning, For Endoscope FEB
    Washer, Cleaner, Automated, Endoscope NVE
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Indicator, Physical/Chemical Sterilization Process JOJ
    Sterilant, Medical Devices MED
    Accessories, Cleaning Brushes, For Endoscope MNL
    Endoscope Maintenance System PUP
    Disinfectant, Subsystem, Water Purification NIH
    System, Dialysate Delivery, Single Patient FKP
    Strip, Test, Reagent, Residuals For Dialysate, Disinfectant MSY
    Disinfectant, Medical Devices LRJ
    Bulb, Inflation, For Endoscope FCY

    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) Rapicide PA Test Strip 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 Veriscan LT Automated Endoscope Leak Tester (PY-CFE) Endo-Leak Tester Adapters (CO-MF) Endo-Leak Tester (CO-MF)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility