BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    i-PAD

    DI: 08809435480003 · Model: NF1200 · CU Medical Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    i-PAD
    Primary DI
    08809435480003
    Version / Model
    NF1200
    Company Name
    CU Medical Systems, Inc.
    Labeler DUNS
    689987964
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-22
    Public Version
    4
    Public Version Date
    2020-03-09
    Public Version Status
    Update
    Public Device Record Key
    470d3541-bc1a-480a-9f50-a4b7a5dce82c

    Device Description

    The i-PAD NF1200 is a semi-automated external defibrillator designed for minimally trained individuals. It provides simple and direct voice prompts and indications for a straightforward rescue operation. The i-PAD NF1200 needs the user to press its SHOCK button to deliver a defibrillating shock. During a rescue operation, it continuously acquires the electrocardiogram (ECG) of the patient. It also conducts arrhythmia detection continuously except during cardiopulmonary resuscitation (CPR). The timing and duration of the CPR are in accordance with the recommendations of the American Heart Association (AHA) 2005 Guidelines for CPR and Emergency Cardiovascular Care (ECC). The i-PAD NF1200 is lightweight and battery powered for maximum portability. Its battery pack has a capacity of 200 shocks (10 hours of operating time.) It delivers a 150-Joule biphasic truncated exponential shock waveform that it compensates for patient impedance by adjusting its timing parameter. If the user decides not to deliver a charge, the i-PAD NF1200 disarms itself by dumping the charge into an internal resistive load. The i-PAD NFI200 is capable of saving data and transmitting them to an external device. Indications for Use The i-PAD NFI200 is used to treat a person suffering from sudden cardiac arrest (SCA) and who exhibits symptoms of · No movement and no response when shaken · No normal breathing Contraindication for Use The device must not be used on a person who: * Is moving or is responsive when shaken * Is breathing normally Target Patients * Adults * Children over 55 lbs or 8 years old * The device is not to be used on children below 8 years old or under 55 lbs Intended User The device is intended for use by persons: * who have been specifically trained in its operation * who have training in cardiopulmonary resuscitation (CPR) or other physician-authorized emergency medical response program in accordance with local and state requirements

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MKJ Automated External Defibrillators (Non-Wearable)

    GMDN Terms

    Code Name
    47910 Non-rechargeable public semi-automated external defibrillator

    Identifiers

    Type ID
    Primary 08809435480003