Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K242820
    Device Name
    Puritan PurSafe Plus Collection and Transport System
    Manufacturer
    Puritan Medical Products LLC
    Date Cleared
    2025-05-27

    (251 days)

    Product Code
    QBD
    Regulation Number
    866.2950
    Why did this record match?
    Applicant Name (Manufacturer) :

    Puritan Medical Products LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Puritan PurSafe Plus Collection and Transport System is an enclosed system intended for the collection, inactivation, and preservation of human upper respiratory specimens suspected of containing SARS-CoV-2. Puritan PurSafe Plus Collection and Transport System can be used for collection, transport, and storage of specimens at 2-4°C and 25-30°C. Specimens collected and stored in the PurSafe Plus Collection and Transport System are suitable for use with legally marketed molecular diagnostic devices.
    Device Description
    Puritan PurSafe Plus Collection and Transport System is comprised of a peel pouch containing a sterile polyester flock swab applicator for collecting clinical specimens and a polypropylene vial containing 1mL PurSafe Plus buffer. PurSafe Plus MK buffer ensures stability of Sars Cov-2 during sample transport/storage at refrigerated to ambient temperature (4-30°C) and is intended to inactivate Sars Cov-2.
    Ask a Question
    K Number
    K162284
    Device Name
    Puritan Fecal Opti-Swab Collection and Transport System
    Manufacturer
    PURITAN MEDICAL PRODUCTS LLC
    Date Cleared
    2016-11-04

    (81 days)

    Product Code
    JSM, JTW, JTX, LIO
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN MEDICAL PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Puritan Fecal Opti-Swab Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.
    Device Description
    Puritan Fecal Opti-Swab Collection and Transport System is comprised of a sterile peel pouch containing a sterile polyester flock swab applicator for collecting clinical fecal and rectal specimens and a polypropylene vial containing 2 ml of Fecal Opti-Swab medium. Fecal Opti-Swab medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability, chloride salts to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent that increases the viscosity of the medium. Sodium thioglycolate and L-cysteine provides an oxygen-reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.
    Ask a Question
    K Number
    K160082
    Device Name
    Puritan Opti-Tranz Cary-Blair Collection and Transport System
    Manufacturer
    PURITAN MEDICAL PRODUCTS LLC
    Date Cleared
    2016-07-29

    (196 days)

    Product Code
    JSM, JTW, LIO
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN MEDICAL PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.
    Device Description
    Puritan Opti-Tranz Cary-Blair Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene tube containing 5 ml of Cary-Blair medium. Cary-Blair medium is a nonnutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.
    Ask a Question
    K Number
    K142366
    Device Name
    Puritan OptiTranz Liquid Stuart Collection and Transport System
    Manufacturer
    PURITAN MEDICAL PRODUCTS LLC
    Date Cleared
    2015-01-09

    (137 days)

    Product Code
    JSM, JTW, LIO
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN MEDICAL PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Puritan OptiTranz Liquid Stuart Collection and Transport System is intended for use in the collection and transport of clinical specimen containing aerobic and fastidious bacteria from patient to the laboratory for bacteriological examination and culture.
    Device Description
    Puritan OptiTranz Collection and Transport System is comprised of a sterile peel pouch containing a rayon or flock tipped swab applicator for collecting specimen and a polypropylene vial containing 1 ml of Stuart liquid medium. Puritan OptiTranz Liquid Stuart Medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability and calcium chloride to provide essential ions that help maintain osmotic balance. Mercaptoacetic acid provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.
    Ask a Question
    K Number
    K131630
    Device Name
    PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
    Manufacturer
    PURITAN MEDICAL PRODUCTS LLC
    Date Cleared
    2013-10-21

    (139 days)

    Product Code
    LIO, JTW, JTX
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN MEDICAL PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Puritan® Amies Medium Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.
    Device Description
    Puritan Amies Medium Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimen and a polypropylene tube containing 4 ml of Amies medium with or without charcoal. The rayon tipped swab applicators are provided in different tip sizes to accommodate various specimen types. Amies medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semi-solid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.
    Ask a Question
    K Number
    K120846
    Device Name
    TRANSPORT CULTURE MEDIUM DEVICE
    Manufacturer
    PURITAN MEDICAL PRODUCTS LLC
    Date Cleared
    2012-06-08

    (80 days)

    Product Code
    LIO, JTW, JTX
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN MEDICAL PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Puritan Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.
    Device Description
    Puritan Liquid Amies Collection and Transport System is comprised of a sterile peel pouch containing a polyester flock swab applicator for collecting specimen and a polypropylene vial containing 1 ml of modified Amies liquid transport medium. The polyester flock swab applicators are provided in two different tip sizes to accommodate various specimen types. Amies liquid medium is a nonnutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride and magnesium chloride to provide essential ions that help maintain osmotic balance. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of aerobic, anaerobic and fastidious bacteria during the transport to the laboratory.
    Ask a Question
    K Number
    K113249
    Device Name
    TRANSPORT CULTURE MEDIUM DEVICE
    Manufacturer
    PURITAN MEDICAL PRODUCTS LLC
    Date Cleared
    2012-03-01

    (119 days)

    Product Code
    JSM, LIO
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    PURITAN MEDICAL PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Puritan UTM – RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the testing laboratory. The specimen transported in the Puritan UTM - RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture.
    Device Description
    Puritan UTM-RT is an enclosed system recommended for the collection and transport of viruses, chlamydiae, mycoplasmas and ureaplasma. The osmotically balanced and buffered culture medium contains Hank's balanced salt solution with a pH indicator, sucrose as a preservative, protein and gelatin as stabilizers. Antimicrobial agents are incorporated to minimize commensal bacterial and fungus contamination. Puritan UTM-RT is comprised of a conical polypropylene vial filled with three 3-mm glass beads and 1.5ml or 3 ml of the transport medium, affixed with a high density polyethylene cap. Each unit of Puritan UTM-RT is provided in a peel pouch containing one of the following swab combinations: 1ml UTM with ultrafine tip HydraFlock® Swab . 3ml UTM with one elongated tip HydraFlock® and one ultrafine tip swab 3ml UTM with elongated tip HydraFlock®® swab . . 3ml UTM with mini-tip HydraFlock® swab, scored shaft 3ml UTM with ultrafine HydraFlock® tip swab . 3ml UTM vial with 2 reg polyester tip swabs, scored shaft 3ml UTM vial with regular polyester tip and one wire/plastic shaft with polyester tip
    Ask a Question

    Page 1 of 1