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510(k) Data Aggregation

    K Number
    K223370
    Device Name
    NeatNick Heel Safety Lancet
    Manufacturer
    Facet Technologies LLC
    Date Cleared
    2023-02-13

    (101 days)

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

    Facet Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeatNick Heel Safety Lancet is a single use device with a sterile blade that is used by medical professionals to obtain a blood sample from the heel of neonates and infants for subsequent diagnostic testing.
    Device Description
    The NeatNick Heel Safety Lancet is a single use, blood sampling device with a sterile blade that are used by medical professionals to obtain a blood sample from the feet of neonates and infants for diagnostic purposes. The NeatNick Lancet incorporates an integral sharps injury prevention feature that also prevents reuse of the lancet. The NeatNick Lancet has been in commercial distribution since 2006. NeatNick Lancets are available in two configurations (Preemie and Full Term) are intended to be used by medical professionals to obtain a blood sample for diagnostic testing. The lancets consist of a stainless steel blade overmolded with low density polyethylene (LDPE) which protects the blade until use and functions as a sterile barrier. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-6. Biocompatibility testing has been conducted per ISO 10993 at a GLP testing facility. The lancet is classified as Class II. The lancet is currently in commercial distribution in the United States and Canada. Since commercial distribution of the current lancets began, there have been no design changes.
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    K Number
    K223099
    Device Name
    Facet Manatee Reusable Lancing Base
    Manufacturer
    Facet Technologies LLC
    Date Cleared
    2022-11-28

    (59 days)

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

    Facet Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Facet Manatee Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adult), and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.
    Device Description
    The Facet Manatee Reuseable Lancet Base is a reuseable blood sampling device used in conjunction with a standard or universal lancet blade to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
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    K Number
    K222539
    Device Name
    Facet Blood Lancets
    Manufacturer
    Facet Technologies LLC
    Date Cleared
    2022-11-18

    (88 days)

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

    Facet Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Facet Lancet is a sterile, disposable single used with a compatible proprietary lancet base (lancing device) to obtain a droplet of capillary blood from the finger for subsequent diagnostic testing. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.
    Device Description
    The Facet Lancet is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic primarily for blood glucose monitoring in diabetic patients. The lancet is available in two needle sizes, 30 gauge and 33 gauge. Facet lancets are intended to be used by diabetic patients to obtain a blood sample for assistance in self-monitoring of their blood glucose levels. The lancets consist of a 30G or 33G stainless steel needle overmolded with low density polyethylene (LDPE) and integral sterility cap. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-9.
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    K Number
    K221433
    Device Name
    Facet 28G Universal Lancet
    Manufacturer
    Facet Technologies LLC
    Date Cleared
    2022-07-15

    (59 days)

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

    Facet Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Facet 28G Universal Lancet is a sterile, disposable single used to obtain a droplet of capillary blood for subsequent diagnostic testing from the finger or an alternative site, such as the palm, upper arm, or forearm. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.
    Device Description
    The Facet 28G Universal Lancet) is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients. The lancets consist of a 28G stainless steel needle overmolded with low density polyethylene (LDPE) and integral sterility cap. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-9.
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