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510(k) Data Aggregation

    K Number
    K241190
    Device Name
    PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
    Manufacturer
    Poonglim Pharmatech Inc.
    Date Cleared
    2024-05-29

    (30 days)

    Product Code
    QNQ, FMI, QNS
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Poonglim Pharmatech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
    Device Description
    PLPT LDV LC Sterile Syringe / PLPT LDV LL Sterile Syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the skin. The device consists of a calibrated barrel (cylinder) with a plunger, and metal tube that is sharpened at one end and at the other end joined to a female connector (hub). This device is intended for various medical applications and is not dedication administration. The distal end of the barrel has a Luer-Cone or Luer-lock connector for the attachment to a hypodermic needle or an administration set. The attached needle is covered by the protective cap which is intended to provide physical protection to the needle tube. The attached needle may have a safety guard that protects the user after use. This product is packed by sterile paper and sterilized by EO gas, and is a single-use device.
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    K Number
    K221860
    Device Name
    PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
    Manufacturer
    Poonglim Pharmatech Inc.
    Date Cleared
    2023-09-15

    (445 days)

    Product Code
    QNQ, FMI, QNS
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Poonglim Pharmatech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
    Device Description
    PLPT LDV LC Sterile Syringe / PLPT LDV LL Sterile Syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body the surface of the skin. The device consists of a calibrated barrel (cylinder) with plunger, and metal tube that is sharpened at one end and at the other end joined to a female connector (hub). This device is intended for various medical applications and is not dedication administration. At the distal end of the barrel has a Luer-Cone or Luer-lock connector for the attachment to a hypodermic needle or an administration set. Attached needle has covered by the protective cap which is intended to provide physical protection to the needle tube. Attached needle may have safety guard that protect the user after use. This product is packed by sterile paper and sterilized by EO gas, and single-use device.
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    K Number
    K210443
    Device Name
    PLPT LDV (Low Dead Volume) Sterile Syringe
    Manufacturer
    Poonglim Pharmatech Inc.
    Date Cleared
    2021-02-16

    (0 days)

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

    Poonglim Pharmatech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PLPT LDV (Low Dead Volume) Sterile Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
    Device Description
    A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedication administration. At the distal end of the barrel is a Luer-lock connector for the attachment to a hypodermic needle or an administration set. This is a single-use device. The PLPT LDV (Low Dead Volume) Sterile Syringe is designed to reduce the fluid waste because of its plunger design.
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    K Number
    K210444
    Device Name
    EZ-Injec LDV Sterile Safety Needle
    Manufacturer
    Poonglim Pharmatech Inc.
    Date Cleared
    2021-02-16

    (0 days)

    Product Code
    QNS
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Poonglim Pharmatech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use to inject fluid into or withdraw fluids from parts of the surface of the skin.
    Device Description
    Sterile single use needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by sterile paper and sterilized by EO gas. The safety guard is placed around the needle after using the product for safety and to prevent reuse. EZ-Injec LDV Sterile Safety Needle helps to decrease fluid volume loss because of its smaller hub inner size.
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    K Number
    K192222
    Device Name
    EZ-Inject Single use Needle
    Manufacturer
    POONGLIM Pharmatech Inc.
    Date Cleared
    2020-05-12

    (270 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    POONGLIM Pharmatech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use to inject fluids into or withdraw fluids from parts of the surface of the skin
    Device Description
    The device consists of a metal tube that is beveled at one end and at the other end join to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by blister paper and sterilized by E.O. gas.
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    K Number
    K172483
    Device Name
    Kopac Sterile Needle
    Manufacturer
    Poonglim Pharmatech Inc.
    Date Cleared
    2018-06-21

    (309 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Poonglim Pharmatech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use to inject fluids into or withdraw fluids from parts of the surface of the skin
    Device Description
    The device consists of a metal tube that is beveled at one end and at the other end join to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by blister paper and sterilized by E.O. gas.
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