Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K221783
    Device Name
    SafetiCET Safety Lancet
    Manufacturer
    NSP Tech Pte Ltd
    Date Cleared
    2022-10-24

    (125 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    NSP Tech Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is designed for obtaining capillary blood sample.
    Device Description
    The SafetiCET Safety Lancet is single use only blood lancet used to puncture the skin to obtain a drop of blood for diagnostic purposes. It is a disposable blood lancet intended for a single use and the device is comprised of a needle encased in a housing made with plastic material commonly used for medical devices. The mechanism of the device includes an integral sharps injury prevention feature which allows the device to be used only once and then renders it inoperable and incapable of further use.
    Ask a Question
    K Number
    K221604
    Device Name
    SafetiHeel, MediHeel, Novaplus
    Manufacturer
    NSP Tech Pte Ltd
    Date Cleared
    2022-08-22

    (81 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    NSP Tech Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is used to obtain capillary blood samples from the heel of newborn and neonatal infants in the healthcare setting by qualified healthcare providers.
    Device Description
    The SafetiHeel Safety Lancet is single use only blood lancet used to puncture the skin to obtain a drop of blood for diagnostic purposes. It is a disposable blood lancet intended for a single use and the device is comprised of a blade encased in a housing made with plastic material commonly used for medical devices. The mechanism of the device includes an integral sharps injury prevention feature which allows the device to be used only once and then renders it inoperable and incapable of further use. The SafetiHeel Safety Lancet is a sterile device and the sterilization is done using the Gamma Irradiation means. The SafetiHeel device is marketed under model numbers SH-065, SH-100 and SH-150. The device is also marketed under trade names such as MediHeel and Novaplus in the USA market. The models for the MediHeel include model number 1003, 1004, 1005 and 1006. For the Novaplus device, the model numbers are 10041 and 10051.
    Ask a Question
    K Number
    K193074
    Device Name
    Bevel Up Holder
    Manufacturer
    NSP Tech Pte Ltd
    Date Cleared
    2020-04-21

    (169 days)

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

    NSP Tech Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bevel Up Holder is used for the collection of blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. The device is to be used by trained healthcare professional only.
    Device Description
    The Bevel Up Holder device is a single use and non-invasive device to be used in venipuncture procedures for the collection of blood specimens. It is to be used as a Tube Holder with blood collection tubes such as the Becton Dickinson Vacutainer® blood collection tube. The Bevel Up Holder device is also used with blood collection needles and blood collection sets such as the Becton Dickinson Eclipse Needle set, Becton Dickinson Vacutainer Multi Sample and Becton Dickinson Safety Lok Blood Collection Set for the collection of blood specimen into the blood collection tubes. The Bevel Up Holder is to be used by trained healthcare professional only and is intended for prescription use. The Bevel Up Holder has a clear plastic holder body with an opening on one end for the insertion of blood collection tube and an interface device connecting feature on the other end for venous access device for connecting to blood collection needle and blood collection set. The connecting end of the venous access device of the Bevel Up Holder (BUH) device allows the adjusting of the position of the venous access device with rotating it.
    Ask a Question
    K Number
    K181743
    Device Name
    Blood Transfer Accessory (BTA)
    Manufacturer
    NSP Tech Pte Ltd
    Date Cleared
    2019-07-30

    (393 days)

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

    NSP Tech Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blood Transfer Accessory is a sterile non invasive device for use in venous blood collection procedures in combination with blood collection devices with a male luer feature.
    Device Description
    The Blood Transfer Accessory (BTA) is a single use device comprising of a holder made from polypropylene plastic with a female luer feature. A stainless-steel needle covered with a rubber sleeve is attached to the inside of the holder. The Blood Transfer Accessory (BTA) has a Holder that encases the Needle preventing any needle stick issue with user. The Holder of the Blood Transfer Accessory (BTA) also house the sample collection tube and protects the user or healthcare personnel from direct contact with blood specimen. The Adapter connected to the blood collection device for the blood transfer. The sample collection tube is inserted from the far end of the holder where the opening is located. This transfer is conducted until the required amount of blood is completed. The sample collection tube is then evacuated from the Blood Transfer Accessory (BTA) by pulling away.
    Ask a Question
    K Number
    K181754
    Device Name
    Blood Collection Accessory (BUCA)
    Manufacturer
    NSP Tech Pte Ltd
    Date Cleared
    2019-07-30

    (393 days)

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

    NSP Tech Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blood Collection Accessory (BUCA) is a single use, sterile and non invasive device used for connecting to venous access device for the collection of blood specimens.
    Device Description
    The Blood Collection Accessory (BUCA) is a single use device comprising of a holder made from polypropylene plastic with a male luer feature. A stainless-steel needle covered with a rubber sleeve is attached to the inside of the holder. The Blood Collection Accessory (BUCA) has a Holder that encases the Needle preventing any needle stick issue with user. The Holder of the Blood Collection Accessory (BUCA) also house the sample collection tube and protects the user or healthcare personnel from direct contact with blood specimen. The Adapter connected to the blood collection device for the blood transfer. The sample collection tube is inserted from the far end of the holder where the opening is located. This transfer is conducted until the required amount of blood is completed. The sample collection tube is then evacuated from the Blood Collection Accessory (BUCA) by pulling it away from the latter.
    Ask a Question

    Page 1 of 1