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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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NA - 00851725007009

Remote Network Station with 19” display
Nihon Kohden Digital Health Solutions, LLC
RNS-9703-019
In Commercial Distribution

  • 00851725007009 ()
RNS-9703-019

  • Centralized patient monitor

Sibel Spacelabs Trek Tablet - 00850064210262

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

  • 00850064210262 ()


  • Wearable multiple vital physiological parameter monitor

Sibel Spacelabs Trek Charger - 00850064210224

No Description
Sibel Health Inc.
900-00046
In Commercial Distribution

  • 00850064210224 ()


  • 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

Central Hub CMS - 00850064210163

Central Hub CMS
Sibel Health Inc.
900-00013
In Commercial Distribution

  • 00850064210163 ()


  • 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

1-Day ANNE Chest Adhesive Pouch - 00850064210026

Pouch of 10 1-Day adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00014
In Commercial Distribution

  • 00850064210026 ()


  • 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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