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    K Number
    K221603
    Device Name
    Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™
    Manufacturer
    Cardinal Health LLC
    Date Cleared
    2022-12-20

    (201 days)

    Product Code
    LZH
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cardinal Health LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. Some patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory. The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.
    Device Description
    The Kangaroo OMNI™ Enteral Feeding Pump, Kangaroo OMNI™ Feeding Sets and Kangaroo™ Accessories consist of an enteral feeding pump and disposable enteral feeding sets along with accessories that deliver fluids via rotary peristaltic tension loop pumping to provide hydration and nutrition for those who do not have the ability to orally ingest food or drinks.
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    K Number
    K211765
    Device Name
    Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
    Manufacturer
    Cardinal Health LLC
    Date Cleared
    2021-11-23

    (168 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cardinal Health LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cardinal Health™ RoyalSilk™ Surgical Gown is a single use, disposable medical device intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70).
    Device Description
    Not Found
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