BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GVS TM, INC.

    Reg #: 3037389071 · FEI: 2013342 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    101
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    GVS TM, INC.
    Registration Number
    3037389071
    FEI Number
    2013342
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1630 W Industrial Park St
    City
    Covina
    State
    CA
    ZIP
    91722
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK060040

    Owner / Operator

    Firm Name
    GVS TM, Inc.
    Operator Number
    10093016
    Address
    1630 W Industrial Park Street
    City
    Covina
    State
    CA
    Postal Code
    91722
    Country
    US

    Products

    Device Name Product Code
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
    System, Detection, Bacterial, For Platelet Transfusion Products MZC
    Microfilter, Blood Transfusion CAK
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass JOD
    Supplies, Blood-Bank KSS
    Separator, Automated, Blood Cell, Diagnostic GKT
    Set, Transfer (Blood/Plasma) KSB

    Proprietary Names

    Platelet Pool and Store Set with in-line Leukocyte Reduction Filter Pall Acrodose PL System Pall eBDS Medsep Freezing bag PALL LEUKOCYTE REMOVAL FILTER, BLOOD RCEZ1T RCEZKS RCQT RN1 RS1 RC1VAE RC2VAE RS1VAE Pall Celeris fPC System Plasma Sample Vial Store Set with in-line Leukocyte Reduction Filter and eBDS Pall Acrodose PLus System Platelet Pool Neocel System NEO1 Component Aliquot System CP1BE Plasma Pooling Bag Plasma Pooling Bags PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE CPS02 PL1BE PL2VAE PL1B, PL6KS PXL8K LPS2 PL6T PXL8C PL3VAE PXL8Y PALL LEUKOCYTE REMOVAL FILTER, PLATELETS LPS2E LPS2KLE Transfer/Freezing Bag Set Phlebotomist Protection Device Leukotrap SC RC Filtration System 430-40 BPF4NEOL LRF6BLA BPFB LRF10BLA LRF10S BPF4BBS BPFAPLUS Pall BPF4B Leukocyte Removal Blood Processing Filter with Attached Tubing and Blood Bag LRFP BPFAPLUSHK BPFBLA 732-86 Pall Acrodose PL System, Platelet Pool and Store Set Modified Plasma Bag SQ40SE SQ40SY SQ40SKLE SB1KLE SQ40SKTE SQ40S SB1E PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) SQ40SK Blood Collection Unit w/o Anticoagulant 736-21 Pall EBDS 400-03E ATSBC1EE ATSBC1EPSB Medsep Plasma Bag LRP6SC2F ATSBC1ESB LRP10BBSL ATSBC1ESE LRP6SCL LRP10BEL ATSBC1EB LRP6BBS Leukotrap System Acrodose PL System Pall Bacterial Detection System (BDS) Pall Autostop Leukocyte Removal Platelet Filter with Tubing 732-80 Pall Acrodose PL System, Platelet Pool and Store Set with eBDS The Pall Celeris FPC System Pall Acrodose PLus System, Platelet Pool and Store Set with in-Line Leukocyte Reduction Filter 732-83 732-82 Platelet Pool and Store Set with eBDS, Pall Platelet Pool and Store Set with Pall eBDS Cutter PPP Harness Store Set with in-line Leukocyte Reduction Filter Cell Wash/Infusion Bag Set 732-42M 732-33M CLX Transfer Bag 732-32M 732-37M NFP1EE

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)