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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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TelePatch Cardiac Monitor - 00862887000371

TelePatch CM PM700 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM700
Not in Commercial Distribution

  • 00862887000371 ()


  • Electrocardiographic ambulatory recorder

Decipher Holter Monitor - 00862887000364

Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM461
Not in Commercial Distribution

  • 00862887000364 ()


  • Electrocardiographic ambulatory recorder

Cardiac Monitor - 00862887000357

Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM500
Not in Commercial Distribution

  • 00862887000357 ()


  • Electrocardiographic ambulatory recorder

CardioPAL SAVI - 00862887000340

CardioPAL SAVI is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM410
Not in Commercial Distribution

  • 00862887000340 ()


  • Electrocardiographic ambulatory recorder

Messenger - 00865190000304

Messenger 5.18 Software Release
SPOK INC.
5.18.0
In Commercial Distribution

  • 00865190000304 ()


  • Alarm application software

A.C.E Red and Blue - 00864918000336

LED light for the treatment of acne
PULSADERM LLC
PD9500
In Commercial Distribution

  • 00864918000336 ()


  • Red/blue light phototherapy unit

Blue LED Acne Clearing Light - 00864918000329

Blue LED Light for the treatment of mild to moderate acne
PULSADERM LLC
PD5000B
In Commercial Distribution

  • 00864918000329 ()


  • Red/blue light phototherapy unit

Pulsaderm RED LED Skin Renewal - 00864918000312

Red LED Light for Wrinkles
PULSADERM LLC
PD5000R
In Commercial Distribution

  • 00864918000312 ()


  • Red/blue light phototherapy unit

A.C.E Blue - 00864918000305

Blue Light for the treatment of acne
PULSADERM LLC
PD9505
In Commercial Distribution

  • 00864918000305 ()


  • Red/blue light phototherapy unit

Mui Scientific - 00678467004161

2 Channel Compressed Air SOM Pump
H & A Mui Enterprises Inc
PIP-5-2SS
Not in Commercial Distribution

  • 00678467004161 ()


  • Manometric gastrointestinal motility analysis system
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