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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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Cart Demo System
BOSTON SCIENTIFIC CORPORATION
M004EPIL220CARTD0
In Commercial Distribution

  • 08714729853985 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
M004EPIL100CARTD0
In Commercial Distribution

  • 08714729853978 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTBD0
In Commercial Distribution

  • 08714729853961 ()


  • Cardiovascular ultrasound imaging system
Cart Demo System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120CARTBD0
In Commercial Distribution

  • 08714729853954 ()


  • Cardiovascular ultrasound imaging system
Cart System
BOSTON SCIENTIFIC CORPORATION
H749ILAB240CARTB0
In Commercial Distribution

  • 08714729853923 ()


  • Cardiovascular ultrasound imaging system
Cart Refurb System
BOSTON SCIENTIFIC CORPORATION
H749ILAB120C271R0
In Commercial Distribution

  • 08714729853916 ()


  • Cardiovascular ultrasound imaging system
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482080 ()
CCZ1205048208

  • Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482050 ()
CCZ1205048205

  • Electrocardiographic long-term ambulatory recording analyser application software
CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482030 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter prep kit with AA battery cleared with Vision 5LR recorder
MORTARA INSTRUMENT, INC.
043272
In Commercial Distribution

  • 10812345029939 ()
  • 20812345029936 ()
  • 30812345029933 ()


  • Electrocardiographic ambulatory recorder
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