BEUDAMED
    Product Code: LRR FDA not classified

    First Aid Kit With Drug

    Unknown

    The First Aid Kit with Drug is a convenience kit containing both medical device components and drug products intended for first aid use; in addition to compliance with the FDA convenience kit guidance, any drug products contained in this kit are subject to applicable drug regulatory requirements. This product's device class is designated as "N," indicating it is not a medical device under FDA's device classification framework, or the classification status is not applicable in the standard sense. The product code is LRR; no regulation number or medical specialty is listed. No special flags apply to this product.

    View on FDA
    510(k)s
    15
    FEI Numbers
    142
    Registration Numbers
    142
    Unique Applicants
    12
    Years Active
    13

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    Basic Information

    Product Code
    LRR
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    SU
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    Unclassified Reason

    6

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 15 510(k) clearances via K numbers.

    K Number Device Name
    K964029 EMERGENCY RELIEF KIT SYSTEM
    K952561 WATER JEL BURN KIT
    K940249 CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING
    K941311 FIRST AID/TRUMA KIT
    K931058 TICK-ATTACK(TM) KIT
    K931634 VARIOUS KITS
    K921762 SHAWNEE PRODUCTS KIT I
    K903393 AUTO FIRST-AID KIT FOR AMERICA
    K896413 COMBINATION 6X-MAGNIFIER AND TWEEZERS
    K895767 ORIGINAL TICK KIT/1ST AID KIT
    K891483 FIRST AID SURVIVAL KIT
    K871376 FIRST AID KIT, VARIOUS SIZES
    K871501 KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE
    K871457 FIRST AID KIT, EYE DRESSING
    K841900 FIRST RESPONSE EMERG. EYE INJURIES

    FEI Numbers

    This FDA classification entry is associated with 142 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 142 registration numbers. Click on an entry to view related FDA registrations.