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510(k) Data Aggregation

    K Number
    K974647
    Device Name
    FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
    Manufacturer
    CUSTOMED, INC.
    Date Cleared
    1998-01-05

    (24 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical drape is used as a protective patient covering such as to isolate a side of surgical incision from microbial and other contamination.
    Device Description
    Fanfold Drape (Surgical Drape) 41"x57"
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    K Number
    K971920
    Device Name
    GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
    Manufacturer
    CUSTOMED, INC.
    Date Cleared
    1997-12-04

    (195 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the patient and personnel from transfer of microorganisms, body fluids and particulate material.
    Device Description
    Surgeon's Gown, Poly Reinforced, Large
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    K Number
    K964011
    Device Name
    SUCTION CATHETER TRAY PRODUCT NO. 900277
    Manufacturer
    CUSTOMED, INC.
    Date Cleared
    1996-11-25

    (49 days)

    Product Code
    LRO
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962652
    Device Name
    URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
    Manufacturer
    CUSTOMED, INC.
    Date Cleared
    1996-10-04

    (88 days)

    Product Code
    KNX
    Regulation Number
    876.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962596
    Device Name
    CUSTOMED BLOOD EXTRACTION KIT
    Manufacturer
    CUSTOMED, INC.
    Date Cleared
    1996-09-27

    (87 days)

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

    CUSTOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Customed Blood Collection Kits are intended to be used by Healthcare professions for venous blood specimen collection and transport, and is for In-Vitro Diagnostic Use only. The kit is used to prepare the skin for sampling, provide blood collection tubes and needles for the sampling procedure, and to cover the sampling site when the procedure is complete.
    Device Description
    The Customed Blood Collection Kits are an assembly of medical products within a pouch. The medical products are disposable, and single use. The primary purpose is for the convenience of the Healthcare professional. The trays are custom to the customer, and include a variety of medical devices that are legally marketed, are exempt, or are grandfathered. These components of the kit are commonly used for blood specimen collection and Customed is not claiming or causing new uses through the intended use of the kit.
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    K Number
    K961442
    Device Name
    UNIVERSAL DRAINAGE TRAY
    Manufacturer
    CUSTOMED, INC.
    Date Cleared
    1996-05-09

    (24 days)

    Product Code
    FCM
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    CUSTOMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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