Duns Number:689987964
Device Description: The i-PAD NF1200 is a semi-automated external defibrillator designed for minimally trained 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 UseThe 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 breathingContraindication for UseThe device must not be used on a person who:* Is moving or is responsive when shaken* Is breathing normallyTarget 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 lbsIntended UserThe 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
Catalog Number
-
Brand Name
i-PAD
Version/Model Number
NF1200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
470d3541-bc1a-480a-9f50-a4b7a5dce82c
Public Version Date
March 09, 2020
Public Version Number
4
DI Record Publish Date
September 22, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 1 |