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510(k) Data Aggregation

    K Number
    K250312
    Device Name
    Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
    Manufacturer
    Medline Industries, LP.
    Date Cleared
    2025-07-02

    (149 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medline Industries, LP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K241778
    Device Name
    Hudson RCI Comfort Flo® CubCannula™
    Manufacturer
    Medline Industries, LP.
    Date Cleared
    2024-12-19

    (182 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medline Industries, LP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hudson RCI Comfort Flo® CubCannula™ is a single use nasal cannula intended to administer respiratory gas to a spontaneously breathing patient through both nostrils delivering flow rates ranging from 1 to 25 LPM. CubCannula™ is a patient interface used to deliver heated and humidified gas to the following populations: - · Neonates, birth to 1 month of age - · Infants, 1 month to 2 years of age - · Children, 2 to 12 years of age CubCannula™ is designed for use in professional healthcare environments and must be prescribed by a physician. CubCannula is used in conjunction with the Humidification System intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.
    Device Description
    The Comfort Flo® CubCannula™ is a single patient use nasal cannula containing two-prongs intended to administer gas to a spontaneously breathing patient through both nostrils. CubCannula™ is a patient interface used as a conduit to deliver heated and humidified gas to the following pediations: neonates, infants, children. The nasal cannula incorporates soft prongs, a soft, silicone, kink and crush resistant lariat, in addition to a color-coded bolo for easy size identification. The CubCannulas will be available in five sizes: Extra Small (XS), Small (XS), Small (XS), Small (XS), Medium (M), Large (L), and Extra Large (XL). The nasal cannula will be secured to the patient's face via use of Hydrocolloid pads (CubPads™) to assist with easy positioning and change out of the cannula during use. The CubCannula™ will be individually packaged with a pair (2) of CubPad™ replacements will be available in a separate package.
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    K Number
    K240163
    Device Name
    Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
    Manufacturer
    Medline Industries, LP.
    Date Cleared
    2024-09-27

    (249 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medline Industries, LP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hudson RCI® Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It is indicated for single use by adult and pediatic (2 years and above) patients in professional healthcare environments. Hudson RCI® Comfort Flo® Plus cannulas are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It is indicated for single use by adult and pediative (12 years and above) patients in professional healthcare environments.
    Device Description
    Hudson RCI® Comfort Flo Nasal Cannulas: Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated humidified air to spontaneously breathing patients. Sizes available include adult and pediatric. Hudson RCI® Comfort Flo Plus Cannulas: Cannula tube is assembled with other components to create a product named Comfort Flo® Plus Cannula with/ without Chin Strap. The Comfort Flo Plus cannulas are intended to be used in conjunction with the Humidification system intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It allows for the safe and effective delivery of heated, humidified oxygen therapy to the patients. The Comfort Flo Plus Cannulas are available in small, medium and large configurations. The chin strap is also offered individually. Hudson RCI® Comfort Flo Plus Cannulas: Comfort Flo Soft Plus cannulas are the same as Comfort Flo Plus cannulas except for head strap. These have a soft/cushioned head strap for patient comfort. It is used as an alternative to oxygen face mask and allows the patient to continue to talk, eat and drink while receiving the therapy. Hudson RCI® Tracheostomy Adaptor: The Hudson RCI® Tracheostomy Adapters are intended to be used in conjunction with tracheostomies in order to provide a secure connection to spontaneously breathing tracheostomy patients for oxygen therapy. It allows for the safe and effective delivery of oxygen therapy to the patient's trachea. The Tracheostomy Adaptor consists of 15mm (female) connector with cap deflector which enables it to be attached to 15M conical connector of tracheostomy tube/ patient connector port and swivel connector (15F/22M) at another end in order to connect with breathing circuit/ humidification system. It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.
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    K Number
    K220333
    Device Name
    Medline Orbis LVL 3 Surgical Gown
    Manufacturer
    Medline Industries, LP.
    Date Cleared
    2022-05-18

    (103 days)

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

    Medline Industries, LP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medline Orbis LVL 3 Surgical Gown is intended to be worn by healthcare professionals during surgical procedures to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The Medline Orbis LVL 3 Surgical Gown is a single use, disposable medical device provided both sterile and nonsterile. The Medline Orbis LVL 3 Surgical Gown meets the Level 3 requirements of ANSI/AAMIPB70:2012 Liquid barrier and performance classification of protective apparel and drapes intended for use in healthcare facilities. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.
    Device Description
    The Medline Orbis LVL 3 Surgical Gown is a single use, disposable medical device provided both sterile and nonsterile.
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