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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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INSTALLATION KIT, SENTINEL 11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522128486 ()
040-5171-00

  • Cardiology information system application software
HOLTER LEADWIRE, EVO/ARIA,WHITE. 1PK
SPACELABS HEALTHCARE (WASHINGTON), INC
ARIA; TAY
Not in Commercial Distribution

  • 10841522123832 ()
700-0370-00

  • Electrocardiographic lead set, reusable
CUSTOM TRENDS,92876
SPACELABS HEALTHCARE (WASHINGTON), INC
Smart Disclosure
In Commercial Distribution

  • 10841522123597 ()
92876

  • Medical equipment clinical data interfacing software
EP JUNCTION LEADSET,PM-3,EU
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522121920 ()
700-0357-01

  • Electrical-only medical device connection cable, reusable
PATIENT CABLE,STANDARD STRESS,PM-3,EU
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522121869 ()
700-0338-01

  • Electrical-only medical device connection cable, reusable
PATIENT CABLE,MICRO-V,PM-3,EU
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522121852 ()
700-0334-01

  • Electrocardiographic lead set, reusable
PATIENT CABLE,MICRO-V,PM-3,US
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522121814 ()
700-0332-01

  • Electrocardiographic lead set, reusable
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
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
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 SP04
In Commercial Distribution

  • 04250903202445 ()
2092504-254

  • Electrocardiographic ambulatory recorder
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