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510(k) Data Aggregation

    K Number
    K221086
    Device Name
    CryoRobot Select System
    Date Cleared
    2022-11-04

    (205 days)

    Product Code
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TMRW Life Sciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CryoRobot Select System is intended to provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm to facilitate the identification, storage, and retrieval of specimens.
    Device Description
    The CryoRobot Select System includes the CryoRobot Select (the robot), CryoBeacons, and the CryoTransporter. The CryoRobot Select System provides an automated liquid nitrogen storage system for oocytes, embryos, and sperm to facilitate the identification, storage, and retrieval of specimens. The system consists of a cryogenic tank, robotic hardware for automation, dedicated robot control software, RFID-enabled storage units ("CryoBeacons") and an insulated container for carrying multiple CryoBeacons ("CryoTransporters"). The robot has an automated container picking system, designed to pick and transport individual CryoBeacons to and from the cryogenic tank. The robot allows users to load 24 CryoBeacons at a time, with a freezer storage capacity of 1,386 through a user-accessible drawer. The system maintains cryogenic temperatures during the specimen storage and retrieval processes. The CryoBeacon is a radio-frequency identification (RFID) enabled storage unit that holds up to eight dimensionally compatible cryodevices. TMRW does not manufacture cryodevices for use with CryoBeacons. Cryodevices compatible with the CryoBeacon include devices up to 135 mm long with the gametes or embryos located at or below 50 mm when measured from the distal end of the closed device. The CryoTransporter is an insulated cryogenic container for carrying 24 CryoBeacons to and from the CryoRobot Select system. The CryoTransporter is filled with liquid nitrogen to maintain a cryogenic environment during CryoBeacon transport. For safe carrying, the CryoTransporter has a handle and a vented, transparent lid for viewing its contents. The CryoTransporter is placed in the drawer of the CryoRobot Select to transfer or retrieve CryoBeacons from the cryogenic tank.
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