BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ALLEVA MEDICAL DEVICES

    Reg #: 3021767551 · FEI: 3021767551 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    58
    Establishment Types
    5
    Classifications
    7

    Registration Details

    Registration Name
    ALLEVA MEDICAL DEVICES
    Registration Number
    3021767551
    FEI Number
    3021767551
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1050 W. Central Avenue, Unit B
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140634

    Owner / Operator

    Firm Name
    Alleva Medical Devices
    Operator Number
    10084505
    Address
    1050 W. Central Avenue, Unit B
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    Max Choi

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW
    Catheter And Tip, Suction JOL
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Catheter, Ventricular, General & Plastic Surgery GBS
    Brush, Dermabrasion, Powered GFE
    Catheter, Cholangiography GBZ
    Bottle, Collection, Vacuum KDQ

    Proprietary Names

    Trocar thoracic catheters extriCARE 3600, canister and Foam Kits (EC3600-100C-E, EC-FOAM-S-E, EC-FOAM-M-E, EC-FOAM-L-E, EC-DOME, EC-DRAPE) F1 Chest Tubes ExtrICARE 3000 Negative Pressure Wound Therapy System 100cc Canister (EC3000-100C) extriCARE 3000 Negative Pressure Wound Therapy System (EC3000) ExtriCARE 3000 Negative Pressure Wound Therapy System 400cc Canister (EC3000-400CC) Yarrow Woundbrush extriCARE 3600 Negative Pressure Wound Therapy System 1000cc Collection Canister (EC3600-1000C-E) Thoracic Catheter - Firm and Thermosensitive PVC, Silicone extriCARE 2400 Negative Pressure Wound Therapy System - 250cc and 400cc collection canister (EC2400-400C-E) 1000mL "Bag" Suction Liner with solidifier (MI285-0015) Vide Wave Three-Chamber Water Seal Chest Drain (ST380-0001) 1800mL Suction Canister (MI130) Transition tube with Luer Connector (ST380-0600) Vide Shore Dry Suction / Water Seal Chest Drain (ST381-0001) 8-12Fr Step-down connector (ST380-0100) Vide Breeze Chest Drain Valve (ST425-0001) 1500mL Rigid Suction Canister (MI202-0004) Vide Sand Dry Seal Chest Drain (ST382-0001) 1800mL Suction Liner (MI158) 2000mL "Bag" Suction Liner (MI287-0008) Vide Transition Tube with Luer Connector (ST380-0600) Rigid High Flow Suction Canister (MI277) Rigid High Flow Suction Canister (MI278) Chest Drain Basket with Clamp (HC063-0002) 3200mL Suction Liner (MI159) Vide Wave Pediatric Water Seal Chest Drain (ST422-0001) Y-Tubing Set for Dual Catheter Connection (ST380-0400) 1000mL Suction Canister (MI129-0013) 2000mL "Bag" Suction Liner with solidifier (MI287-0015) 800mL Rigid Suction Canister (MI055-0012) 3000mL "Bag" Suction Liner (MI288-0008) 1500mL "Bag" Suction Liner with solidifier (MI286-0015) Vide Wave Three-Chamber Water Seal Chest Drain, with inline sampling port connector (ST380-0006) Vide Manual Suction Bulb, Non-Sterile (ST380-0700) 1200mL Rigid Suction Canister (MI056-0012) 1500mL Suction Canister (MI358-0013) Chest Drain Basket with Hanger and Clamp (HC063-0001) 1000mL "Bag" Suction Liner (MI285-0008) Vide Shore Dual Chamber Dry Suction Water Seal Drain (ST423-0001) 1300mL Suction Canister (MI129) 3000mL "Bag" Suction Liner with solidifier (MI288-0015) 2000mL Suction Canister (MI301-0013) 3000mL Suction Canister (MI302-0013) Patient stepped connector (for 16-40Fr catheter) (ST380-0300) 1500mL "Bag" Suction Liner (MI286-0008) Vide Shore Pediatric Dry Suction Water Seal Chest Drain (ST424-0001) 3200mL Suction Canister (MI131) 1500mL Suction Lid Liner (MI243) 3000mL Suction Lid Liner (MI248) Y-Tubing Set for Suction-Dual Drain Connection (ST380-0500) Vide Sterile End Cap for In-Line Connector (ST380-0900) 1300mL Suction Liner (MI157) 1000mL Suction Lid Liner (MI217) In-line Needleless Sampling Port Connector (ST380-0200) extriCARE 2400 NPWT Pump and canister (2400, EC2400-400C-E) ; Bandage Dressings (EC2400-SO/MN/LO/IM-E) ExtriCARE 1000 Negative Pressure Wound Therapy 50cc Canisters (EC1000-CAN) ExtriCARE 1000 Negative Pressure Wound Therapy System (EC1000)

    Establishment Types

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