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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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PROFEMUR RENAISSANCE STEM REDUCED SZ 11
Microport Orthopedics Inc.
PLS0R411
In Commercial Distribution

  • PLS0R411 ()
  • M684PLS0R4111 ()

  • Length: 130 Millimeter
PLS0R411

  • Press-fit hip femur prosthesis, modular
PROFEMUR RENAISSANCE STEM REDUCED SZ 10
Microport Orthopedics Inc.
PLS0R410
In Commercial Distribution

  • PLS0R410 ()
  • M684PLS0R4101 ()

  • Length: 125 Millimeter
PLS0R410

  • Press-fit hip femur prosthesis, modular
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.
NF1200
In Commercial Distribution

  • 08809435480003 ()


  • Non-rechargeable public semi-automated external defibrillator
PROFEMUR E Hip Stem, Size 9
Microport Orthopedics Inc.
PHA03149
In Commercial Distribution

  • PHA03149 ()
  • M684PHA031491 ()

  • Length: 166 Millimeter
PHA03149

  • Press-fit hip femur prosthesis, modular
PROFEMUR E Hip Stem, Size 8
Microport Orthopedics Inc.
PHA03148
In Commercial Distribution

  • PHA03148 ()
  • M684PHA031481 ()

  • Length: 156 Millimeter
PHA03148

  • Press-fit hip femur prosthesis, modular
PROFEMUR E Hip Stem, Size 7
Microport Orthopedics Inc.
PHA03147
In Commercial Distribution

  • PHA03147 ()
  • M684PHA031471 ()

  • Length: 151 Millimeter
PHA03147

  • Press-fit hip femur prosthesis, modular
PROFEMUR E Hip Stem, Size 6
Microport Orthopedics Inc.
PHA03146
In Commercial Distribution

  • PHA03146 ()
  • M684PHA031461 ()

  • Length: 146 Millimeter
PHA03146

  • Press-fit hip femur prosthesis, modular
PROFEMUR E Hip Stem, Size 5
Microport Orthopedics Inc.
PHA03145
In Commercial Distribution

  • PHA03145 ()
  • M684PHA031451 ()

  • Length: 142 Millimeter
PHA03145

  • Press-fit hip femur prosthesis, modular
PROFEMUR E Hip Stem, Size 4
Microport Orthopedics Inc.
PHA03144
In Commercial Distribution

  • PHA03144 ()
  • M684PHA031441 ()

  • Length: 137 Millimeter
PHA03144

  • Press-fit hip femur prosthesis, modular
PROFEMUR E Hip Stem, Size 3
Microport Orthopedics Inc.
PHA03143
In Commercial Distribution

  • PHA03143 ()
  • M684PHA031431 ()

  • Length: 134 Millimeter
PHA03143

  • Press-fit hip femur prosthesis, modular
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