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510(k) Data Aggregation

    K Number
    K250907
    Device Name
    Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
    Manufacturer
    Sol-Millennium Medical, Inc.
    Date Cleared
    2025-04-30

    (35 days)

    Product Code
    JKA, FPA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sol-Millennium Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sol-Guard™ XtraThin Wall Safety Pull button blood collection set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male Luer adaptor, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and should remain under the direct supervision of a clinician. The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
    Device Description
    Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder. The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.
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    K Number
    K242291
    Device Name
    SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
    Manufacturer
    Sol-Millennium Medical Inc.
    Date Cleared
    2024-11-20

    (110 days)

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

    Sol-Millennium Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body. The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable is used to inject fluids into, or withdraw fluids from, the body. The Luer Lock Syringe (Low Dead Space) with Safety needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
    Device Description
    The Luer Lock and Slip Tip syringe (Low Dead Space) without Needle is a sterile, single-use, standard 3-piece piston hypodermic syringe. The Luer lock and Slip Tip syringe (Low Dead Space) with exchangeable needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. The Luer Lock Syringe (Low Dead Space) with Safety Needle is a Low Dead Space syringe in combination with a safety needle. The safety needle contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
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    K Number
    K242099
    Device Name
    Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle
    Manufacturer
    Sol-Millennium Medical Inc.
    Date Cleared
    2024-10-22

    (96 days)

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

    Sol-Millennium Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The syringe without needle is used to inject fluids into, or withdraw fluids from, the body.
    Device Description
    The Slip Tip and Eccentric Tip Syringe without Needle is a sterile, single-use, standard 3 piece piston. The device is packed individually and EO sterilized with 10-6 SAL. The proposed device includes different specifications: 1ml Slip Tip Syringe without Needle 3ml Slip Tip Syringe without Needle 5ml Slip Tip Syringe without Needle 10ml Slip Tip Syringe without Needle 20ml Slip Tip Syringe without Needle 30ml Slip Tip Syringe without Needle 60ml Slip Tip Syringe without Needle 10ml Eccentric Tip Syringe without Needle 20ml Eccentric Tip Syringe without Needle 60ml Eccentric Tip Syringe without Needle
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    K Number
    K241821
    Device Name
    Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle
    Manufacturer
    Sol-Millennium Medical Inc.
    Date Cleared
    2024-09-20

    (88 days)

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

    Sol-Millennium Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luer Lock Syringe with Exchangeable Needle is used to inject medicines and vaccines into, or withdraw fluids from. the body. The Luer Lock Syringe with Safety Needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Luer Lock Syringe with Blunt Fill Needle is used for aspiration from multi-dose medicine vials.
    Device Description
    The Luer Lock Syringe with Exchangeable Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. The Luer Lock with Safety Needle is a syringe and needle combination with the safety needle. It contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Safety needle can be pre-attached or aside the syringe. The Luer Lock Syringe with Blunt Fill Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. It is used for aspiration from multi-dose medicine vials. The proposed devices are offered in various gauge sizes and length. The proposed devices are available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. The device is for medical professionals use only and for prescription use only. - Luer Lock Syringe with Safety Needle (Syringe range: 1ml, 3ml, 5ml,10ml; Needle range: 20G, 21G, 23G, 25G; Needle length from 5/8" to 1 1/2"). The Safety needle can be pre-attached or aside the syringe. - Luer Lock Syringe with Exchangeable Needle (Syringe range: 3ml, 5ml, 10ml, Needle range: 20G, 21G, 22G, 23G, 25G; Needle length from 5/8" to 1 1/2"). - Luer Lock Syringe with Blunt Fill Needle (Syringe range: 3ml, 5ml, 10ml, Needle: 18G, Needle length:1 1/2").
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    K Number
    K220713
    Device Name
    Sol-Guard Auto-disable Syringe
    Manufacturer
    Sol-Millennium Medical Inc.
    Date Cleared
    2023-05-04

    (419 days)

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

    Sol-Millennium Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sol-Guard Auto-Disable Syringe is intended for aspiration and injection of fluids into the body. In addition, the Sol-Guard™ Auto-Disable Syringe is designed to prevent syringe and needle reuse.
    Device Description
    The SOL-GUARD Auto-Disable syringe is a sterile, single-use, 3-part hypodermic syringe with an auto-disable feature that is intended to deliver a fixed dose of medicine/vaccine immediately after filling. The SOL-GUARD Auto-Disable syringe has a fixed needle and plunger rod with affixed metal clip which is designed for the prevention of the syringe and needle re-use by automatically activating the clip and locking the plunger after injection. The syringe is individually blister packaged, and EtO sterilized with SAL of 106. This syringe is intended for aspiration and injection of fluids.
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    K Number
    K222744
    Device Name
    Sol-M Luer Lock Syringe
    Manufacturer
    Sol-Millennium Medical Inc.
    Date Cleared
    2022-10-11

    (29 days)

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

    Sol-Millennium Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sol-M Luer Lock Syringe is intended for aspiration of medications and fluids into the body.
    Device Description
    The Sol-M Luer Lock Syringe is used to aspirate and inject fluid/medication into the body. The syringe is a sterile, single-use, 3-part syringe with luer lock conical connection. The Sol-MTM Luer Lock Syringe consists of the following components: Barrel, Plunger, Gasket. In addition to being used manually, the Sol-MTM Luer Lock Syringe can also work with a powerdriven syringe pump, with the luer lock tip connected to the IV administration line to deliver specific volume of fluid/medication. The syringe is individually blister packaged, and EtO sterilized with SAL of 10-6. The Sol-M™ Luer Lock Syringe is provided in 1, 3, 5, 10, 20, 30, and 60ml volume.
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    K Number
    K213718
    Device Name
    SOL-GUARD Safety Pull Button Collection Set
    Manufacturer
    Sol-Millennium Medical, Inc.
    Date Cleared
    2022-08-30

    (279 days)

    Product Code
    JKA, FPA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sol-Millennium Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOL-GUARD™ Safety Pull-Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens . When used without the male Luer adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician. The recommended use of the device is to activate the needle safety feature prior to removal the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
    Device Description
    SOL-GUARD™ Safety Pull-Button Blood Collection Set, is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder. The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.
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    K Number
    K202732
    Device Name
    SOL-CARE IV Bag Safety Connector
    Manufacturer
    Sol-Millennium Medical Group
    Date Cleared
    2021-11-03

    (411 days)

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

    Sol-Millennium Medical Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOL-CARE IV Bag Safety Connector is designed for drug administration to I.V. bag without using sharp hypodermic needle attached to a drug pre-filled syringe. It incorporates a shielded needle to allow safe access through the injection port of I.V. bag.
    Device Description
    The device provides a simple, cost-effective solution to an everyday problem - how to make drug additions to an IV bag without using an exposed hypodermic needle attached to a drug-filled syringe. It incorporates a shielded needle to allow safe access through the 'rubber bung' on the INJECTION tail of an IV bag.
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    K Number
    K182146
    Device Name
    Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
    Manufacturer
    Sol-Millennium Medical, Inc.
    Date Cleared
    2018-12-03

    (117 days)

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

    Sol-Millennium Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sol-M Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The Sol-Care Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Sol-Care Safety Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Sol-M Blood Collecting Set is intended to be used with vacuum blood collection tube for the collection of venous blood.
    Device Description
    The proposed devices are blood collection devices form a channel between patient's vein and the vacuum blood collection tube intended for collection of blood. The proposed devices are divided into several types, the configuration for each type of proposed device are provided as follows: Blood Collection Needle – one piece, Blood Collection Needle – Direct, Blood Collection Needle – Multi piece, Safety Blood Collection Needle – Direct, Safety Blood Collection Needle – Multi piece, Safety Blood Collection Needle w/Holder – One piece, Safety Blood Collection Needle w/Holder - Direct. In addition, the proposed devices are divided into several types and available in different specifications.
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    K Number
    K163073
    Device Name
    Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
    Manufacturer
    Sol-Millennium Medical, Inc.
    Date Cleared
    2017-05-19

    (198 days)

    Product Code
    JKA, FPA, REG
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sol-Millennium Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sol-Care Safety Blood Collection Needle(with and without Pre-attached Tube Holder) is a single, winged blood collection needle to be used for blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needlestick injury
    Device Description
    The Sol-Care Safety Blood Collection Needle Set (Butterfly Needle) is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term infusion of intravenous fluids. The Butterfly Needle Set is available with a 21, 23 or 25 gauge needle with Butterfly Wings and a Safety Shield with tubing leading to a covered needle assembly and Tube Holder. The product is available with and without the Tube Holder. The Sol-Care Safety Blood Collection Needle consists of: - Stainless steel cannula (Intravenous end and Non-patient end of Cannula) - Wings (Color coded according to needles gauge) - Tubing - Female luer adaptor - Intravenous (IV) needle protector (covers the needle before use) The optional SOL-M™ Blood Collection Tube Holder and SOL-M™M Blood Culture Holder include a male luer adapter for attachment to the Sol-Care Safety Blood Collection Needle. The Sol-Care Safety Blood Collection Needle has a sharps injury prevention feature. The Butterfly Wing Assembly consists of a needle assembly and a Safety Shield. After use, the health care professional can pull back on the tubing while holding the butterfly wing and the needle will retract and lock into the Safety Shield. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal. The devices are sterilized by Ethylene Oxide Gas. The Safety Blood Collection Needle is supplied in a hard Tray Pack while the Safety Blood Collection Needle with a preattached Tube Holder is supplied in a soft Tray Pack. Twenty-Five Safety Blood Collection Needles with a pre-attached Tube Holders are packaged in a chipboard box while fifty Safety Blood Collection Needles are packaged in a chipboard box. Each Tray Pack is labeled with the contents and the appropriate information per the Medical Device Directive and FDA's Quality System Regulation and Labeling requirements, 21CFR Part 801.
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