BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ThermoGenesis Corp.

    Reg #: 2950374 · FEI: 1000123765 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    35
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    ThermoGenesis Corp.
    Registration Number
    2950374
    FEI Number
    1000123765
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2890 Kilgore Rd
    City
    RANCHO CORDOVA
    State
    CA
    ZIP
    95670
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK070006

    Owner / Operator

    Firm Name
    Thermogenesis Corp.
    Operator Number
    9023456
    Address
    2890 Kilgore Road, --
    City
    Rancho Cordova
    State
    CA
    Postal Code
    95670
    Country
    US
    Correspondent
    Jason - Le

    Products

    Device Name Product Code
    Refrigerator, Freezer, Blood Storage KSE
    Cord Blood Processing System And Storage Container OAO
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG

    Proprietary Names

    BioArchive AXP AutoXpress Platform; AXP System Counterweight, AXP AXP Large Oval Bucket Adapter Set Start Up Accessory Kit, AXP AXP Docking Station AXP Adapter, 101-102 mm Round Bucket AXP Device AXP Adapter Set, Sorvall 11754/11297 Freezing Bag Set Component Retaining Clip Set, AXP AXP Sorvall 11754 Bucket Pads, Package Of 2 AXP Medium Oval Bucket Adapter Set PXP-100 Disposable Cartrdige, Qty 36 PXP-1000 Disposable Cartridge PXP-LAVARE Control Module PXP-LAVARE Docking Station PXP Disposable Cartridge, Box of 2 PXP Disposable Cartridge, Box of 12 PXP Docking Station PXP-1000 Docking Station PXP-LAVARE Disposable Cartridge, Qty. 12 PXP-LAVARE Disposable Cartridge, Qty. 2 PXP-LAVARE Disposable Cartridge, Qty. 36 PXP-LAVARE Disposable Cartridge PXP Disposable Cartridge, Box of 36 PXP-1000 Control Module PXP-100 Disposable Catridge PXP Control Module AXP II Device Freezing Bag Set-48 set AXP II Docking Station AXP Processing Bag Set X-LAB System X-WASH System

    Establishment Types

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