Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K220230
    Device Name
    AMSure Enteral Feeding Pump
    Manufacturer
    Amsino International Inc.
    Date Cleared
    2022-11-10

    (287 days)

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

    Amsino International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMSure® Enteral Feeding Pump is intended to work with the disposable enteral feeding sets to deliver nutritional formula to the gastrointestinal system of adult patients who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Only intended for adult patients, not for pediatric use. The AMSure® Enteral feeding pump is intended to be used in healthcare facilities by licensed healthcare professional users only. The AMSure® Enteral feeding pump is for use only with Amsino AMSure® feeding sets.
    Device Description
    The AMSure® enteral feeding pump is intended to work with the disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food
    Ask a Question
    K Number
    K200051
    Device Name
    PUGGLE Enteral Feeding Pump and Feeding Set
    Manufacturer
    Amsino International Inc.
    Date Cleared
    2020-09-25

    (259 days)

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

    Amsino International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to deliver nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The PUGGLE® Enteral Feeding Pump and Feeding Set are intended to be used in clinical or home care settings by users ranging from laypersons to physicians. The PUGGLE® Enteral Feeding Pump and Feeding Set shall be used together only.
    Device Description
    The PUGGLE® Enteral Feeding Pump and Feeding Set consists of an enteral feeding pump and disposable enteral feeding sets that deliver formula via rotary peristaltic pumping system to provide nutrition for those who do not have the ability to orally ingest food. The pump incorporates a graphical interface that walks the users through the PUGGLE® Enteral Feeding Pump and Feeding Set setup feed rates and volumes as well as other feeding options. The PUGGLE® Enteral Feeding Pump and Feeding Set come with three different connector types: standard, ENFit®, and ENFit® with Transition Connector.
    Ask a Question
    K Number
    K181445
    Device Name
    AMSure Hydrophilic Intermittent Catheter
    Manufacturer
    Amsino International Inc.
    Date Cleared
    2018-10-01

    (122 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Amsino International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INTENDED USE: The AMSure® Hydrophilic Intermittent Catheter is inserted into the patient's bladder and indicated for intermittent use for the purpose of drainage of urine from the bladder. The catheter does not contain a balloon on its tip. An optional Water sachet is included to activate the hydrophilic-coated surface prior to use. The target populations for the subject device are Adults and Pediatrics.
    Device Description
    The AMSure® Hydrophilic Intermittent Catheter is a urethral catheter intended to be passed through the urethra during urinary catheterization and into the bladder to drain urine. It is hydrophilic and lubricous coated flexible tube owns a hydrophilic polymer in the surface which makes the catheter highly lubricious and good adhesion upon contact with water, saline solution, body fluids. The catheter and gripper is manufactured with medical grade PVC, the surface is coated with a hydrophilic lowfriction coating (polyvinyl pyrrolidone, or PVP), the water sachet is with USP grade sterile water. Each catheter is provided in sterile, single-use packages, intended to be used by adults and pediatrics.
    Ask a Question
    K Number
    K181423
    Device Name
    AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
    Manufacturer
    Amsino International Inc.
    Date Cleared
    2018-09-07

    (99 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Amsino International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush - For over the-counter use: For moistening absorbent wound dressing and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. - For prescription use: For moistening absorbent wound dressing and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
    Device Description
    AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water and sterile normal saline for wound flush are intended to be used in clinical or home care and should only be used by clinicians familiar with the treatment of possible complications. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP<40>. The bottle and cap are made by HDPE, the inner induction sealed film is foil. The devices are offered in 100mL bottles.
    Ask a Question

    Page 1 of 1