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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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Stratus® CS STAT Fluorometric Analyzer Cannula - 00842768004445

Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube in the sample manager.
Siemens Healthcare Diagnostics Inc.
10445064
In Commercial Distribution

  • 00842768004445 ()
  • 00630414009797 ()
CCANS

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated

Stratus® CS STAT Fluorometric Analyzer Cannula - 00842768004438

For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGARD® closure, to be used on the Stratus® CS STAT Fluorometric Analyzer.
Siemens Healthcare Diagnostics Inc.
10445063
In Commercial Distribution

  • 00842768004438 ()
  • 00630414009780 ()
CCANBD

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated

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

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

MoMe® Kardia - B690MK10

MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.
Infobionic, Inc.
01854
In Commercial Distribution

  • B690MK10 ()


  • Electrocardiography telemetric monitoring system transmitter
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