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510(k) Data Aggregation

    K Number
    K183540
    Device Name
    Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
    Manufacturer
    NeoMed, Inc.
    Date Cleared
    2019-04-30

    (131 days)

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

    NeoMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single Use Oral/Enteral Syringes with ENFit Connector (provided sterile and non-sterile): 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 orally or enterally. It is intended to be used in clinical and non-clinical settings by users ranging from clinicians to laypersons in all age groups. Reusable Oral/Enteral Syringes with ENFit Connector (provided non-sterile): 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 orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.
    Device Description
    NeoMed Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied sterile or non-sterile, and single use or multiuse. They are provided in varying colors and sizes ranging from 12 mL to 60 mL nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids. NeoMed Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip that has the additional low dose tip design feature, syringe plunger, syringe gasket, and supplied sterile or non-sterile, and single use or multiuse. They are provided in varying colors and sizes ranging from 1 mL to 6 mL nominal capacity. The integral syringe tip is a female ENFit connector with the additional low dose tip design feature which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids. Reusable Standard ENFit Syringes (12 mL to 60 mL) and reusable Low Dose Tip ENFit Svringes (1 mL to 6 mL) are supplied non-sterile and are intended for single patient use. They are provided in varying colors and sizes ranging from 1 mL to 60 mL nominal capacity.
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    K Number
    K161039
    Device Name
    NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
    Manufacturer
    NeoMed, Inc.
    Date Cleared
    2016-06-17

    (65 days)

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

    NeoMed, Inc.

    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 orally or 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) in all age groups.
    Device Description
    NeoMed Oral/Enteral Syringes with ENFit® connector (12 mL to 100 mL) are standard piston style syringes consisting of a syringe barrel (vented or non-vented) with integral ENFit® syringe tip, syringe plunger, and syringe gasket. They are supplied in sizes ranging from 12 mL to 100 mL nominal capacity, sterile or non-sterile, with or without a syringe tip cap, and in varying colors. The integral syringe tip is a female ENFit® connector designed to be compatible only with enteral access devices or accessories having ENFit® compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids. NeoMed Low Dose Tip Oral/Enteral Syringes with ENFit® connector (0.5 mL to 6 mL) are standard piston style syringes consisting of a syringe barrel with integral ENFit® syringe tip that has the additional low dose tip design feature, syringe plunger, and syringe gasket, They are supplied in sizes ranging from 0.5 mL to 6 mL nominal capacity, sterile or nonsterile, with or without a syringe tip cap, and in varying colors. The integral syringe tip is a female ENFit® connector with the additional low dose tip design feature designed to be compatible only with enteral access devices or accessories having ENFit® compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.
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    K Number
    K152857
    Device Name
    NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2015-12-17

    (78 days)

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

    NEOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeoConnectTM Enteral Syringe with ENFit™ Connector: The device is indicated for use as a dispenser, a measuring 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) in all age groups. NeoConnect™ NeoSecure™ Tip Cap: A NeoConnect™ Enteral Syringe with ENFit™ connector accessory used to prevent fluid loss and contamination of syringe contents until ready for use.
    Device Description
    The NeoMed NeoConnect™ Enteral Syringes with ENFit™ connector are standard piston style syringes consisting of a syringe barrel with an integral ENFit™ syringe tip, syringe plunger, syringe gasket, and supplied with or without a syringe tip cap. They are provided in varying sizes ranging from 0.5 mL to 100 mL nominal capacity. The integral syringe tip is a female ENFit™ connector which is compatible only with enteral access devices having ENFit™ male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume. The NeoConnect™ NeoSecure™ Tip Cap is supplied with the NeoConnect™ Enteral Syringe with ENFit™ connector or sold separately (sterile or non-sterile). It is an ENFit™ compatible closure cap for the tip of the syringe.
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    K Number
    K143344
    Device Name
    NeoMed NeoConnect Enteral Syringes with ENFit Connector
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2015-04-09

    (139 days)

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

    NEOMED, INC.

    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 via extension sets and feeding tubes in neonatal and small pediatric patients.
    Device Description
    The NeoMed NeoConnect™ Enteral Syringes are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied with a syringe tip cap. They are provided in varying sizes ranging from 0.5ml to 100ml nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with feeding tubes and extension sets that have ENFit male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.
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    K Number
    K122373
    Device Name
    NEOMED ORAL/ENTERAL SYRINGE
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2012-09-20

    (45 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is used to inject fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.
    Device Description
    The NeoMed Oral / Enteral Syringe is specifically designed for administration of enteral liquids to neonatal and small pediatric patients. The NeoMed Oral / Enteral Syringe is a standard piston syringe which is incompatible with luer-lock and intravenous devices. The NeoMed Oral / Enteral Syringes are compatible with NeoMed enteral-only connectors, the NeoMed extension sets and NeoMed feeding tubes to form a dedicated system that prevents wrong-route administration of non-IV fluids and other competitive enteral/feeding tube, extension set type products that do not utilize a luer-lock system. They possess translucent barrels to provide visualization of fluid contents and volume, and patented orange lettering/gradient markings which coordinate with NeoMed orange extension sets and feeding tubes. NeoMed Oral / Enteral Syringes are manufactured as a single piece molded barrel that does not rely on adapters to create an oral tip. The NeoMed Oral / Enteral Syringes possess design features that prevent connectivity to luer type devices and hence prevents the chance that a feeding tube could be infused into the IV line. The NeoMed Oral / Enteral Syringe device consists of the following components: - Syringe Barrel - Syringe Plunger - Syringe Gasket - Syringe Tip - Syringe Cap
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    K Number
    K120182
    Device Name
    NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2012-04-19

    (90 days)

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

    NEOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for short-term use < 30 days in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement.
    Device Description
    The NeoMed Gastrointestinal Tube and Accessories is a PVC single lumen catheter that is used to deliver liquid nutritional media. This NeoMed PVC feeding tube is designed to connect with other NeoMed accessories such as the NeoMed Extension tubing under FDA clearance K100288 and NeoMed oral syringe under FDA clearance K092908. The device consists of the following main components: a feeding tube single lumen catheter and a one-piece molded enteral only connector hub with integral tethered connection closure plug. The catheter tubing has an orange radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The tip is closed. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration.
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    K Number
    K100288
    Device Name
    NEOMED ENTERAL ONLY EXTENSION SET
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2010-08-03

    (183 days)

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

    NEOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoMed Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.
    Device Description
    The NeoMed Enteral Only Extension Set is a sterile disposable for single patient use only device designed to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. The device consists of flexible PVC tubing designed to connect existing feeding tubes (nasogastric, oralgastric, etc) to various delivery systems in including pumps and syringes. The set consists of tubing with an enteral connector (catheter tip) and an oral syringe connector not compatible with IV tubing or stopcocks. The NeoMed Enteral Only Extension Set provides an orange stripe for easy quick identification of enteral feeding lines as well as an "Enteral Only" tag and slide clamp to provide the additional safety assurance for connection errors.
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    K Number
    K092908
    Device Name
    NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2010-03-10

    (169 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is used to inject fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.
    Device Description
    The NeoMed Sterile Syringe is specifically designed for administration of enteral liquids to neonatal patients. The NeoMed Sterile Syringe is a standard piston syringe which is incompatible with luer-lock and intravenous devices. The NeoMed Sterile Syringes are compatible with NeoMed enteral-only connectors, the NeoMed orange extension sets and feeding tubes to form a dedicated system that prevents wrong-route administration of non-IV fluids and other competitive enteralfeeding tube, extension set type products that do not utilize a luer-lock system. They possess translucent barrels to provide visualization of fluid contents and volume, and patented orange lettering/gradient markings which coordinate with NeoMed orange extension sets and feeding tubes. NeoMed Sterile Syringes are manufactured as a single piece molded barrel that does not rely on adapters to create an oral tip. The NeoMed Sterile Syringes possess design features that prevent connectivity to luer type devices, and hence prevents the chance that a feeding tube could be infused into the IV line. The NeoMed Sterile Syringes will be available in 1ml, 3ml, 6ml, 35ml, and 60ml individual packs. The NeoMed Sterile Syringe device consists of the following components: - Syringe Barrel - Syringe Plunger - Svringe Gasket - Syringe Tip - Syringe Cap
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    K Number
    K082238
    Device Name
    NEOMED POLYURETHANE FEEDING TUBE
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2008-10-01

    (55 days)

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

    NEOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoMed Polyurethane Feeding Tube is intended for nasogastric or orogastric 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.
    Device Description
    The NeoMed Polyurethane Feeding Tube is a polyurethane single lumen catheter that is used to deliver liquid nutritional media. The device consists of the following main components: a feeding tube single lumen catheter, a hub with tethered connection closure plug, and a connector.
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    K Number
    K081515
    Device Name
    NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2008-07-21

    (52 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoMed Dual Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood, monitor blood pressure, or administer fluids intravenously.
    Device Description
    The NeoMed Dual Lumen Umbilical Catheter is a silicone dual lumen catheter with natural white barium sulfate included for radiopacity. The device consists of the following main components: a dual lumen umbilical catheter, a hub, and two extension legs, one with a three-way stopcock and the other with an injection site.
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