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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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Monitor with DOX SPO2, NIBP, HR, Printer and Temp
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNVP3
In Commercial Distribution

  • B438506DNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical
Monitor with DOX SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNP3
In Commercial Distribution

  • B438506DNP3US0 ()


  • Multiple vital physiological parameter monitoring system, clinical
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
APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.
APDM, INC.
V2C
In Commercial Distribution

  • B628OPALV2C0 ()
OPALV2C

  • Kinesiology ambulatory recorder
APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628DSV2C0 ()
DSV2C

  • Kinesiology ambulatory recorder
APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628APV2C0 ()
APV2C

  • Kinesiology ambulatory recorder
Dongle for Scanner S600 ARTI
ZIRKONZAHN SRL
ZBAC1401
In Commercial Distribution

  • ZBAC1401 ()


  • Dental milling system, CAD/CAM, laboratory
No Description
BIOTRICITY INC
1.0
In Commercial Distribution

  • B635BIOTRES100 ()


  • Electrocardiography telemetric monitoring system transmitter
No Description
BIOTRICITY INC
1.0
In Commercial Distribution

  • B635BIOFLUX1A0 ()


  • Electrocardiography telemetric monitoring system transmitter
No Description
BIOTRICITY INC
1.0
In Commercial Distribution

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


  • Electrocardiography telemetric monitoring system transmitter
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