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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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BioSticker™ - 00850005949008

The BioSticker™ System is a wearable remote monitoring system intended for continuous collection of physiological data in home and healthcare settings.
BIOINTELLISENSE, INC.
BIOST01021F
In Commercial Distribution

  • 00850005949008 ()
  • 10850005949005 ()
  • 20850005949002 ()


  • Electrocardiography telemetric monitoring system transmitter

BioPlex 2200 - 00847865002820

BPX2200, Analyzer System, Refurbishment
BIO-RAD LABORATORIES, INC.
6600000RM
In Commercial Distribution

  • 00847865002820 ()

  • 1 Each
6600000RM

  • Multiplex analyser IVD, laboratory, automated

BioPlex 2200 - 00847865002813

BioPlex 2200 Instrument
BIO-RAD LABORATORIES, INC.
6600000
In Commercial Distribution

  • 00847865002813 ()

  • 1 Each
6600000

  • Multiplex analyser IVD, laboratory, automated

NA - 04931921115213

Transmitter, Multi Parameter, WEP-4208
NIHON KOHDEN CORPORATION
ZS-940PA
In Commercial Distribution

  • 04931921115213 ()
ZS-940PA

  • Electrocardiography telemetric monitoring system transmitter

NA - 04931921115145

Transmitter, ECG and Resp, WEP-4208
NIHON KOHDEN CORPORATION
ZS-910PA
In Commercial Distribution

  • 04931921115145 ()
ZS-910PA

  • Electrocardiography telemetric monitoring system transmitter

NA - 04931921115107

Transmitter, ECG SPO2 and Resp, L-BAND 1.4 GHz
NIHON KOHDEN CORPORATION
ZM-531PA
In Commercial Distribution

  • 04931921115107 ()
ZM-531PA

  • Electrocardiography telemetric monitoring system transmitter

NA - 04931921115091

Transmitter, ECG SPO2 and Resp, 608 UHF MHz
NIHON KOHDEN CORPORATION
ZM-530PA
In Commercial Distribution

  • 04931921115091 ()
ZM-530PA

  • Electrocardiography telemetric monitoring system transmitter

NA - 04931921115084

Transmitter, ECG and Resp, L-BAND 1.4 GHz
NIHON KOHDEN CORPORATION
ZM-521PA
In Commercial Distribution

  • 04931921115084 ()
ZM-521PA

  • Electrocardiography telemetric monitoring system transmitter

NA - 04931921115077

Transmitter, ECG and Resp, 608 UHF MHz
NIHON KOHDEN CORPORATION
ZM-520PA
In Commercial Distribution

  • 04931921115077 ()
ZM-520PA

  • Electrocardiography telemetric monitoring system transmitter

NA - 04931921106631

Transmitter
NIHON KOHDEN CORPORATION
ZM-921PA
In Commercial Distribution

  • 04931921106631 ()


  • Electrocardiography telemetric monitoring system transmitter
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