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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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PATHFINDER SL, SENTINEL10 - 10841522103193

UPGRADE: PA-DIGITAL TO PATHFINDER SL, SENTINEL10
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200, PATHFIND
Not in Commercial Distribution

  • 10841522103193 ()
043-0128-00

  • Electrocardiographic long-term ambulatory recording analyser

PathfinderSL - 10841522103087

SENTINEL 10 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522103087 ()
040-1708-00

  • Electrocardiographic long-term ambulatory recording analyser

Intesys Clinical Suite - 10841522100116

SMART DISCLOSURE,92810
SPACELABS HEALTHCARE (WASHINGTON), INC
92810
Not in Commercial Distribution

  • 10841522100116 ()
V5.2.3

  • Medical equipment clinical data interfacing software

MUSE - 00195278458070

MUSE NX R2 SOFTWARE
Ge Medical Systems Information Technologies, Inc.
NX R2
In Commercial Distribution

  • 00195278458070 ()
4101010-002

  • Cardiology information system application software

CAM - 00195278421449

CAM 14 - MDR
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
14
In Commercial Distribution

  • 00195278421449 ()
900995-102

  • Electrocardiograph, professional, multichannel

CASE - 00195278403643

CASE V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V7.0
In Commercial Distribution

  • 00195278403643 ()
2035123-001

  • Electrocardiograph, professional, multichannel

CardioSoft - 00195278364661

CARDIOSOFT V7.0 SP7.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V7.0
In Commercial Distribution

  • 00195278364661 ()
2006300-112

  • Electrocardiograph, professional, multichannel

LOCALISA® - 00643169006874

ELECTRODE 9670590 5BX LOCALISA
MEDTRONIC, INC.
9670590
In Commercial Distribution

  • 20643169006878 ()
  • 00643169006874 ()


  • Cardiac mapping system reference patch

CardioDay - 04250903202520

The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
getemed Medizin- und Informationstechnik AG
v2.7 Global
In Commercial Distribution

  • 04250903202520 ()
2092504-270

  • Electrocardiographic ambulatory recorder

CardioDay - 04250903202469

The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
getemed Medizin- und Informationstechnik AG
v2.6 Global
In Commercial Distribution

  • 04250903202469 ()
2092504-260

  • Electrocardiographic ambulatory recorder
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