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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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CardioDay V 2.5 - 04250903200144

The CardioDay V2.5 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 V2.5 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
Global
In Commercial Distribution

  • 04250903200144 ()
2092504-001

  • Electrocardiographic ambulatory recorder

Merge Hemo - 00842000101079

No Description
MERGE HEALTHCARE SOLUTIONS INC.
RCSV2
In Commercial Distribution

  • 00842000101079 ()


  • Patient monitoring system module, multifunction

Merge Hemo - 00842000100966

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.4
In Commercial Distribution

  • 00842000100966 ()


  • Patient monitoring system module, multifunction

Merge Hemo - 00842000100874

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.3
In Commercial Distribution

  • 00842000100874 ()


  • Patient monitoring system module, multifunction

Merge Hemo - 00842000100430

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.2
In Commercial Distribution

  • 00842000100430 ()


  • Patient monitoring system module, multifunction

Merge Hemo - 00842000100027

No Description
MERGE HEALTHCARE SOLUTIONS INC.
9.4
In Commercial Distribution

  • 00842000100027 ()


  • Patient monitoring system module, multifunction

MLCL Upgrade - 00195278940193

Upgrade Kit MLCL V9.0
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278940193 ()
5973644

  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

MLCL Client Software - 00195278931504

Software Medical Device GE Client Software V9.0
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278931504 ()
5973597

  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

CASE - 00195278617644

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

  • 00195278617644 ()
3031234-001

  • 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
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