BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medivators Inc

    Reg #: 1651395 · FEI: 3003012447 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    86
    Establishment Types
    5
    Classifications
    18

    Registration Details

    Registration Name
    Medivators Inc
    Registration Number
    1651395
    FEI Number
    3003012447
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3150 Pollok Drive
    City
    Conroe
    State
    TX
    ZIP
    77303
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062969

    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
    Gown, Surgical FYA
    Endoscope Channel Accessory ODC
    Colonoscope And Accessories, Flexible/Rigid FDF
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Pump, Air, Non-Manual, For Endoscope FEQ
    Accessories, Cleaning Brushes, For Endoscope MNL
    Endoscopic Irrigation/Suction System OCX
    Accessories, Cleaning, For Endoscope FEB
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Bulb, Inflation, For Endoscope FCY
    Endoscopic Bite Block MNK
    Endoscope Introducer Kit NWU
    Bronchoscope Accessory KTI
    Non-Surgical Gown OEA
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Drape, Surgical, Antimicrobial KKX
    Bottle, Collection, Vacuum KDQ
    Endoscopic Access Overtube, Gastroenterology-Urology FED

    Proprietary Names

    Medline Sterile Disposable Surgical Gowns DEFENDO Valve and Connector Kit (100310, 100312, 100315) DEFENDO Air/Water and Suction Valves (100305, 100306, 100311) DEFENDO Air/Water/Suction and Biopsy Valves and Kits (1003xx) Endo Smartcap UCR Adaptor ENDOGATOR Tubing for ENDO STRATUS Pump ENDOGATOR Tubing for EGP-100 Irrigation Pump ENDOGATOR Single Use Auxiliary Water Jet Connector for Pentax Endoscopes (100242) ENDOGATOR Channel Adapter (100136) ENDOGATOR Single Use Auxiliary Water Jet Connectors for Olympus Endoscopes (100241) ENDOGATOR Backflow Valve (100126) ENDOGATOR Tubing for Endostat II/III Unit 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 ENDOGATOR Hybrid Irrigation Tubing 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) Endo Gator Hybrid Tubing Kits EndoStratus Irrigation Pump EGA-500 Endo Smartcap Endoscope Leak Tester Model ZUTR10003 Defendo Fujifilm 700 series valve kits DEFENDO Air/Water and Suction Valves (100306) DEFENDO Air/Water and Suction Valves (100305) EndoGator Irrigation Tubing Pediatric Bite Block Adult Bite Block Endogator Irrigation Pump Model EGP-100 DEFENDO Air/Water/Suction and Biopsy Valve (100316) DEFENDO Air/Water and Suction Valves (100317) DEFENDO Valve and Connector Kit (100315) Defendo Valve Kit Via procedure kit ENDOGATOR Kit Endo Carry-On Procedure Kit Defendo Y-Opsy Irrigator (100303) Scope Buddy Endoscope Flushing Aid (PY-CFE) Impervious Gown Medline (200352) Impervious Gown Welmed (200350, 200351) Defendo Cleaning Adapter Non-Sterile (4008055) EndoStratus CO2 Insufflator EGA-501 Veriscan LT Automated Endoscope Leak Tester (PY-CFE) Endo-Leak Tester Adapters (CO-MF) Endo-Leak Tester (CO-MF) DEFENDO Air/Water/Suction and Biopsy Valves and Kits (100301, 100305, 100310) Transport Pad Defendo Fujifilm 500/600 Air/Water, Suction, and Biopsy Valve (100313) Defendo Fujifilm 500/600 Air/Water and Suction Valve (100314) Defendo Fujifilm 500/600 Air/Water, Suction, and Biopsy Valve and ENDOGATOR Connector (100312) Endogator Auxiliary Water Jet Connector Endogator System Polyp Trap Single Polyp Trap Quad Polyp Trap Double AmplifEYE Defendo Single Use Cleaning Adapter for Olympus Endoscopes (4000096)

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)