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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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MD ACUTE VIRTUAL COLLABORATOR NOTIFY ME 1.0
GE HEALTHCARE
NotifyMe V1.0
Not in Commercial Distribution

  • 00840682152754 ()


  • Patient health record information system
Software Medical Device GE Client Software V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145763 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
Software Medical Device INW V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145756 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
MUSE NX
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
NX
In Commercial Distribution

  • 00840682142809 ()


  • Cardiology information system application software
Guidewire
GALT MEDICAL CORP.
SGW-011-08
In Commercial Distribution

  • 00841268100541 ()
  • 10841268100548 ()
  • 20841268100545 ()

  • Outer Diameter: 0.035 Inch
SGW-011-08

  • Peripheral vascular guidewire, manual
SENTINEL 11 HL7 TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
In Commercial Distribution

  • 10841522130922 ()
040-1724-01

  • Cardiology information system application software
SENTINEL/LIFESCREEN PRO RAPID ANALYSIS KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifescreen Pro
In Commercial Distribution

  • 10841522129773 ()
040-5173-00

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129551 ()
040-1766-00

  • Cardiology information system 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
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
No Description
Implicity Inc.
V1.1.4
In Commercial Distribution

  • 03770025266008 ()
IM007

  • Cardiology information system application software
PATHFINDER SL ANALYSER
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522129537 ()
98000SL

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL V11.X UPGRADE
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129506 ()
040-5172-00

  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129438 ()
040-1708-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 RDT TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129414 ()
040-1725-01

  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT DE
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129407 ()
040-1756-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT DN
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
Not in Commercial Distribution

  • 10841522129391 ()
040-1755-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT NL
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129384 ()
040-1754-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
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