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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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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

Biotricity - B635BIOTRES100

No Description
BIOTRICITY INC
1.0
In Commercial Distribution

  • B635BIOTRES100 ()


  • Electrocardiography telemetric monitoring system transmitter

BIOFLUX - B635BIOFLUX1A0

No Description
BIOTRICITY INC
1.0
In Commercial Distribution

  • B635BIOFLUX1A0 ()


  • Electrocardiography telemetric monitoring system transmitter

BIOFLUX - B635BIOFLUX100

No Description
BIOTRICITY INC
1.0
In Commercial Distribution

  • B635BIOFLUX101 ()
  • B635BIOFLUX100 ()
  • B635BIOFLUX105 ()
  • B635BIOFLUX104 ()
  • B635BIOFLUX103 ()
  • B635BIOFLUX102 ()


  • Electrocardiography telemetric monitoring system transmitter

NA - 10841983103909

NTX DISPOSABLE POUCH, 100/BOX
NIHON KOHDEN AMERICA, INC.
A/NTX-DISP
In Commercial Distribution

  • 10841983103909 ()
  • 10841983103908 ()
A/NTX-DISP

  • Electrocardiography telemetric monitoring system transmitter

Dxpress Reader - 10743816001362

Dxpress Reader/1 Unit
PRINCETON BIOMEDITECH CORPORATION
LSR-2000
In Commercial Distribution

  • 10743816001362 ()
LSR-2000-00

  • Microplate reader IVD, semi-automated

Ohmega R - 08717775955016

No Description
Medical Measurement Systems B.V.
G2-1
In Commercial Distribution

  • 08717775955016 ()


  • Oesophageal motility analysis system

Impedance/pH,6 imp channels,2 pH antimony,acid LPR + oes,LES locator - 08717775954095

Adult, 6.9 Fr
Medical Measurement Systems B.V.
MMS-Z2L-A-LES
In Commercial Distribution

  • 08717775954095 ()
  • 08717775954118 ()


  • Oesophageal motility analysis system

Impedance/pH, 6 imp channels, 1 pH antimony, LES locator - 08717775954071

Adult, 6.9 Fr
Medical Measurement Systems B.V.
MMS-Z1-A-LES
In Commercial Distribution

  • 08717775954071 ()
  • 08717775954088 ()


  • Oesophageal motility analysis system

Impedance/pH, 6 imp channels, 1 pH antimony, Infant, 1.5 cm spacing - 08717775953098

6.4 Fr
Medical Measurement Systems B.V.
MMS-Z1-I
In Commercial Distribution

  • 08717775953104 ()
  • 08717775953098 ()


  • Oesophageal motility analysis system
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