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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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KIT,START-UP,3-L ECG IEC,NIBP,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104985 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical
KIT,START-UP,5-L ECG IEC,NIBP,SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104954 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical
KIT,START UP KIT UPGRADE,SKIN TEMP SENSOR
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104947 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical
KIT,START UP KIT UPGRADE,5-L ECG AAMI
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104930 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical
KIT, DM3 UPDATE, V1.8
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102981 ()
V1.8

  • Multiple vital physiological parameter monitoring system, clinical
KIT, DM3 UPDATE, V1.7
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102974 ()
V1.7

  • Multiple vital physiological parameter monitoring system, clinical
MONITOR, COMPACT, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
91369
In Commercial Distribution

  • 10841522108716 ()
R-91369

  • Multiple vital physiological parameter monitoring system, clinical
No Description
Sira Medical, Inc.
1
In Commercial Distribution

  • G67910 ()


  • Surgical planning/navigation-enhancement system
VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general-purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the CLAROX plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware).
VSI Co., Ltd.
VX-100
In Commercial Distribution

  • 18800124900014 ()
  • 08800124900017 ()


  • Portable basic diagnostic x-ray system, digital
Mapping System
BOSTON SCIENTIFIC CORPORATION
M004OPLINSTALL2EN0
In Commercial Distribution

  • 00191506055370 ()
M004OPLINSTALL2EN0

  • Cardiac mapping system
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