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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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BodyGuardian - 00852132007095

Remote Monitoring System Kit
PREVENTICE TECHNOLOGIES, INC.
BG1001MAZ
Not in Commercial Distribution

  • 00852132007095 ()


  • Medical networking interface unit

BodyGuardian - 00852132007057

Remote Monitoring System Kit
PREVENTICE TECHNOLOGIES, INC.
BG1001MAS
Not in Commercial Distribution

  • 00852132007057 ()


  • Medical networking interface unit

BodyGuardian - 00852132007002

Remote Monitoring System Kit
PREVENTICE TECHNOLOGIES, INC.
BG1001
Not in Commercial Distribution

  • 00852132007002 ()


  • Medical networking interface unit

ZeroWire - 00851455007256

ZEROWIRE TX, DVI, SDI, W/ACCESSORIES, SINGLE CHANNEL, CHINA, WT-P11-13
Nds Surgical Imaging LLC
90T0033
Not in Commercial Distribution

  • 00851455007256 ()


  • Medical networking interface unit

ZeroWire - 00851455007249

ZEROWIRE RX, DVI, W/ACCESSORIES, SINGLE CHANNEL, CHINA, WR-P11-11
Nds Surgical Imaging LLC
90T2032
Not in Commercial Distribution

  • 00851455007249 ()


  • Medical networking interface unit

X-Series - 00851113007918

External Syncing Unit - Multi-Channel Kit (PAN 1026A)
ADVANCED BRAIN MONITORING, INC.
ES31-1001, ES31-1003
In Commercial Distribution

  • 00851113007918 ()
  • 00851113007901 ()


  • Medical networking interface unit

X-Series, X8 - 00851113007833

Bluetooth Dongle - PAN 1026
ADVANCED BRAIN MONITORING, INC.
31-1003, 31-1004
In Commercial Distribution

  • 00851113007833 ()


  • Medical networking interface unit

X-Series - 00851113007475

External Syncing Unit - Multi-Channel Kit
ADVANCED BRAIN MONITORING, INC.
ES31-1001, ES31-1003
In Commercial Distribution

  • 00851113007406 ()
  • 00851113007475 ()


  • Medical networking interface unit

X-Series, X8 - 00851113007260

Bluetooth Dongle
ADVANCED BRAIN MONITORING, INC.
31-1003
In Commercial Distribution

  • 00851113007260 ()


  • Medical networking interface unit

CardioLabs - 00851074007385

ECG Recorder (Event)
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007385 ()
RX93030-012

  • Telemetric electrocardiographic ambulatory recorder
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