i-PAD

GUDID 08809435480003

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

CU Medical Systems, Inc.

Non-rechargeable public semi-automated external defibrillator

• Primary Device ID: 08809435480003
• NIH Device Record Key: 470d3541-bc1a-480a-9f50-a4b7a5dce82c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-PAD
• Version Model Number: NF1200
• Company DUNS: 689987964
• Company Name: CU Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809435480003 [Primary]

FDA Product Code

• MKJ: Automated External Defibrillators (Non-Wearable)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-09
• Device Publish Date: 2014-09-22