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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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Ultraview DM3 - 00851920007033

The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
ZOE MEDICAL INCORPORATED
91330-NT
In Commercial Distribution

  • 00851920007033 ()
175-6210

  • Multiple vital physiological parameter monitoring system, clinical

Ultraview DM3 - 00851920007026

The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
ZOE MEDICAL INCORPORATED
91330-N
In Commercial Distribution

  • 00851920007026 ()
175-6200

  • Multiple vital physiological parameter monitoring system, clinical

Ultraview DM3 - 00851920007019

The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
ZOE MEDICAL INCORPORATED
91330-MT
In Commercial Distribution

  • 00851920007019 ()
175-6110

  • Multiple vital physiological parameter monitoring system, clinical

Ultraview DM3 - 00851920007002

The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
ZOE MEDICAL INCORPORATED
91330-M
In Commercial Distribution

  • 00851920007002 ()
175-6100

  • Multiple vital physiological parameter monitoring system, clinical

Sibel Spacelabs Trek Tablet - 00850064210262

No Description
Sibel Health Inc.
900-00043
In Commercial Distribution

  • 00850064210262 ()


  • Wearable multiple vital physiological parameter monitor

Central Hub Speaker - 00850064210194

Central Hub Speaker
Sibel Health Inc.
900-00004
In Commercial Distribution

  • 00850064210194 ()


  • Wearable multiple vital physiological parameter monitor

ANNE View Patient Monitor - 00850064210132

Patient monitor consisting of a mobile tablet and the ANNE View software. The ANNE View Patient Monitor connects to the ANNE Chest sensor, ANNE Limb sensor, and compatible devices for the real-time display of physiological data.
Sibel Health Inc.
900-00012
In Commercial Distribution

  • 00850064210132 ()


  • Wearable multiple vital physiological parameter monitor

7-Day ANNE Chest Adhesive Shelf Box - 00850064210101

Box of 30 7-Day adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00010
In Commercial Distribution

  • 00850064210101 ()


  • Wearable multiple vital physiological parameter monitor

ANNE Bedside Wireless Charger - 00850064210057

Bedside charger for the ANNE Chest and ANNE Limb sensors.
Sibel Health Inc.
900-00008
In Commercial Distribution

  • 00850064210057 ()


  • Wearable multiple vital physiological parameter monitor

7-Day ANNE Chest Adhesive Pouch - 00850064210019

Pouch of 5 7-Day Adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00038
In Commercial Distribution

  • 00850064210019 ()


  • Wearable multiple vital physiological parameter monitor
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