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510(k) Data Aggregation

    K Number
    K180236
    Device Name
    VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
    Manufacturer
    VR MEDICAL TECHNOLOGY CO., LTD
    Date Cleared
    2019-01-18

    (354 days)

    Product Code
    FPD, KNT, PIF
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    VR MEDICAL TECHNOLOGY CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days. The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which are intended to reduce the misconnection between the following applications: I.V. system and Enteral Feeding System. The EFES is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.
    Device Description
    The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the qastro intestinal tract of neonatal, pediatric and is not intended for use beyond 30 days. They are sterile, individually packaged. The orange color coding provides easy visual recognition of the enteral connection. They are designed with a radiopague stripe for X-ray visualization to confirm proper feeding tube placement. They are marked with French size and markings to assist tube placement or check for migration. A tethered plug for connector closure is incorporated when not in use. The Enteral Feeding Extension Sets ("EFES") are intended to provide access from the feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in multiple configurations: with and without an in-line Y port and lengths. The EFES are sterile disposable device for single patient use only. The EFES is designed to connect existing feeding tubes (nasogastric, gastric, etc.) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector. The EFES consists of flexible tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors.
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    K Number
    K162159
    Device Name
    VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
    Manufacturer
    VR Medical Technologies, LLC
    Date Cleared
    2017-04-28

    (269 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    VR Medical Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VR Medical VCare 1000-300S Negative Pressure Wound Therapy System is an integrated wound management system, indicated for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
    Device Description
    The VR Medical VCare 1000-300S System is an AC-Powered portable suction device, with battery backup, that provides localized negative pressure when used with the VR Medical Perme-Foam Dressing to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the disposable fluid collection canister, and a foam dressing kit. The kit consists of polyurethane foam, suction bell with connecting (drainage) tube and clamp, and polyurethane drape. The single-use foam dressing kit is packaged in a PE/PET peel pouch bag, which is gamma sterilized. The Foam Dressing Kit (VR Medical Perme-Foam Dressing) can be sold alone or as a part of the VCare 1000-300S System in two sizes: - Large foam dressing kit - Medium foam dressing kit - The Foam Dressing can be used for up to 72 hours of continuous use.
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    K Number
    K162188
    Device Name
    Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)
    Manufacturer
    VR MEDICAL TECHNOLOGY
    Date Cleared
    2016-09-22

    (49 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    VR MEDICAL TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) for patients in all age groups.
    Device Description
    The Enteral Syringe with ENFit Connector (10 ml to 60 ml) and the Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) are both sterile, standard piston style enteral syringes with an integrated female ENFit compatible connector compliant to the requirements of ISO DIS 80369-3, First Edition, Small-bore Connectors for Liquids and Gases in Healthcare Applications – Part 3: Connectors for Enteral Applications and designed to be compatible with male ENFit connectors. The Enteral Syringe with ENFit Connector has capacities of 10, 20, 30 and 60 ml and is available in two different connector confiqurations: Centerline and Offset. The Enteral Syringe with ENFit Low Dose Tip is a low dose syringe and has capacities of 1. 3 and 5 ml. The ENFit Lose Dose tip is a modification of the ENFit connector designed for the delivery of low doses of fluids for enteral feeding.
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    K Number
    K132709
    Device Name
    VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
    Manufacturer
    VR MEDICAL
    Date Cleared
    2014-07-30

    (335 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    VR MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The products mentioned above are designed for disposable use and should be changed at least every 24 hours.
    Device Description
    The Heat and Moisture Exchanger and Filter (HMEF) consists of a plastic body which incorporates an electrostatic/ mechanical filter pad. 22 mm female / 15 mm male connectors in accordance with ISO 5356 (Anaesthetic and respiratory equipment-Conical connectors- Part 1: Cones and sockets) and a luer lock connector which is only used for gas monitoring.
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    K Number
    K110853
    Device Name
    VR MEDICAL ENTERAL ORAL SYRINGE
    Manufacturer
    VR MEDICAL
    Date Cleared
    2011-05-13

    (46 days)

    Product Code
    FPD
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    VR MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oral Enteral Syringe is intended for the delivery of liquid medication, formula and breast milk.
    Device Description
    The Oral Enteral Syringe is intended as a single use, sterile, device for the delivery of liquid medication, formula and breast milk. The Oral Enteral Syringe comes in multiple volume sizes ranging from 1cc to 60cc [e.g., 1cc, 3cc, 10cc, 20cc, 30cc and 60cc]. The VR Medical Oral Enteral Syringe, as well as the predicate device [Phillips Children's Medical Venture Oral/ Enteral Syringe (K100099)] has 'labeling' on the device itself, i.e., highly visible labeling on side of barrel marked ORAL/ENTERAL ONLY, and the utilization of bright orange colorant for the plunger and cap that easily distinguishes the syringe for feeding and not other uses. The Oral Enteral Syringe incorporates safety connectors which eliminate the risk of IV administration through the feeding tube, i.e., the safety connectors will not mate with Luer Lock or Leur slip fittings. The VR Medical Oral Enteral Syringe design incorporates various components, e.g., barrels, plungers, caps and end caps, which are comprised of commercially available materials with demonstrated acceptable biocompatibility, as listed below: Barrel Material: Polypropylene 370Y Piston Material: Thermoplastic Elastomer IR307 Plunger Material: Polypropylene 370Y Plunger Colorant: Orange Pigment* Cap Material: Polypropylene 370Y Cap Colorant: Orange Pigment (P21024) Barrel Gradation Ink: PPE Ink Series (on outside of barrel) Nozzle Material: Polypropylene 370Y (molded with barrel) The Oral Enteral Syringe does not contain natural rubber latex, DEHP, or BPA.
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