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510(k) Data Aggregation

    K Number
    K223788
    Device Name
    The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
    Date Cleared
    2023-09-15

    (270 days)

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

    MedSource International LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter are indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Blood Control I.V. Safety Catheter and the MedSource ClearSafe Blood Control I.V. Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy, appropriateness for the solution being administered and duration of the therapy.
    Device Description
    The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheters are a safety medical device used for inserting a catheter into a patient's body for the delivery of fluids or drainage of fluids from a patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury. In addition, this device also secures the needle (used to insert the catheter) within the catheter body with either a push button or slide safety mechanism, thus protecting healthcare and other personnel from accidental needle sticks. The MedSource TrueSafe Blood Control I.V. Safety Catheter is comprised of a sharp needle attached to a needle hub with a catheter attached to a catheter hub. In the catheter hub there is a valve that, when activated, allows for the movement of fluids. In the 'inactivated' state prior to insertion of a male Luer, the movement of fluids is restricted. When the needle is retracted with the push button from the catheter the needle retracts into the body of the catheter and the needle is fully encapsulated. The MedSource ClearSafe Blood Control I.V. Safety Catheter blood control mechanism is identical to the MedSource TrueSafe Blood Control I.V. Safety Catheter. The only difference in design features is the ClearSafe Blood Control has a slide safety mechanism that retracts the needle into the catheter body. The needle is also fully encapsulated to prevent accidental needlesticks. There is no difference in clinical use between the two models and the use of one over the other depends on user preference. The MedSource TrueSafe and ClearSafe Blood Control Safety I.V. Catheter gauges are color coded for positive identification and range from 14G to 24G.
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    K Number
    K161779
    Device Name
    MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
    Date Cleared
    2016-11-03

    (127 days)

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

    MedSource International, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
    Device Description
    The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter are safety medical devices used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter are comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The components combine for an ergonomic design that incorporate a safety feature that when the device is withdrawn, the needle is completely enclosed within the chamber protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded post-use. The retraction mechanism is activated by the push of a button.
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    K Number
    K150611
    Device Name
    MedSource ClearSafe Safety IV Catheter
    Date Cleared
    2015-07-15

    (127 days)

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

    MedSource International

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedSource ClearSafe Safety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource ClearSafe Safety IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
    Device Description
    The MedSource ClearSafe Safety IV Catheter is a medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. The device is equipped with a safety feature intended to prevent needle stick injuries. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse. The MedSource ClearSafe Safety IV Catheter is comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The components combine for an ergonomic design that incorporate a safety feature that when the device is withdrawn, the needle is completely enclosed within the chamber. The retraction mechanism is activated by the user using only one hand by means of a sliding motion. The device is available in six gauges identified also by specific colors.
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    K Number
    K150333
    Device Name
    MedSource Sharps Dart
    Date Cleared
    2015-05-08

    (87 days)

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

    MedSource International, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedSource Sharps Datt is a non-sterile single-use disposable sharps container with a permanent closure system for a contaminated 1 ml or smaller syringe. Its intended use is by health care professionals in a setting where standard sharps containers are not accessible such as EMS, home healthcare, and laboratories. Its permanent closure system protects the user prior to disposal by incineration or decontamination by autoclave.
    Device Description
    The MedSource Sharps Dart (MSD) sharps container consists of two injected molded parts-a tubular tapered cone and a polypropylene closure. Its small size of 0.6 L qualifies it as a pocket sharps container as defined by ISO 23907 First Edition 2012-09-01, Sharps injury protection-Requirements and test methods-Sharps containers. It is designed for the storage, such sharps as small syringes, blood needles, lancets, and angio-caths prior to disposal consideration. It's intended to be used in remote settings for sharps containers are not convenient and accessible such as EMS, home healthcare, etc. It is a single use device.
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    K Number
    K140442
    Device Name
    MEDSOURCE SELECTABLE IV SET
    Date Cleared
    2014-04-22

    (60 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDSOURCE INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein
    Device Description
    Not Found
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    K Number
    K140402
    Device Name
    MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
    Date Cleared
    2014-04-03

    (44 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDSOURCE INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.
    Device Description
    Not Found
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    K Number
    K131555
    Device Name
    MEDSOURCE IV SAFETY CATHETER
    Date Cleared
    2014-01-31

    (247 days)

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

    MEDSOURCE INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedSource IV Safety Catheter is indicated to sample blood or administer fluids intravenously. The MedSource IV Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
    Device Description
    The MedSource IV Safety Catheter is a safety medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse. The device comprises a sharp needle attached to a hub which projects into a chamber. In the 'unactivated' state prior to insertion, the needle and hub are 'locked' in position. There exists a retraction mechanism for 'unlocking' the needle such that on activation of this mechanism it is withdrawn and completely enclosed within the chamber. This mechanism for retracting the needle preferably includes a coiled spring or other elastic components. The retraction mechanism is activated by the user using only one hand by means of a lever or 'switch'.
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    K Number
    K120424
    Device Name
    MEDSOURCE IV ADMINSTRATION SET
    Date Cleared
    2012-07-11

    (149 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDSOURCE INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedSource IV Administration Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.
    Device Description
    The MedSource IV Administration Set is a sterile, single use intravascular administration set used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device includes: 1. Guard for Closure 2. Closure Piercing Device (spike)- Vented with Drip flow rate (either 10, 15, or 60 drops/mL 3. Housing for air-vent with filter 4. Drip Chamber 5. Fluid Filter 6. Tubing 7. Flow Regulator 8. Injection Site (Y-site, Needleless) 9. Male Luer Lock Fitting 10. Protective Cap for Male Fitting
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    K Number
    K080339
    Device Name
    MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
    Date Cleared
    2008-10-27

    (262 days)

    Product Code
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDSOURCE INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for Use: MedSource Endotracheal Tube: The device is intended for oral or nasal intubation and for airway management. Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylet: The device is intended for oral or nasal intubation and for airway management.
    Device Description
    MedSource Pre-Loaded Endotracheal Tube (Cuffed & Uncuffed) with and without Stylet: • Constructed of Polyvinylchloride • Single lumen tube with or without a cuff; • Tapered tip with Murphy Eye; • Clear medical-grade tubing(polyvinyl) with graduations; • Connector with check valve; • Pre-loaded with Stylet having a low friction coating; • Various sizes • Sterile Single-Use Device
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    K Number
    K081516
    Device Name
    MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
    Date Cleared
    2008-08-26

    (88 days)

    Product Code
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDSOURCE INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is for prescription use.
    Device Description
    A one piece, single use, full-size, light-weight PVC mask system which includes: - A Universal breathing tube. - A One-way filtered valve. - A Head strap. - With Oxygen Port or Without Oxygen Port. - Packaged for easy portability and quick access.
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