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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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Care Orchestrator - 00606959055414

Care Orchestrator, Clinical data collection management information system application software
Respironics, Inc.
1.19
In Commercial Distribution

  • 00606959055414 ()
1126366

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959054790

Care Orchestrator, Clinical data collection management information system application software
Respironics, Inc.
Care Orchestrator, Clinical data collection software - 1
In Commercial Distribution

  • 00606959054790 ()
1126366

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959053922

Care Orchestrator, Clinical data collection management information system application software
Respironics, Inc.
1.17
In Commercial Distribution

  • 00606959053922 ()
1126366

  • Medical equipment clinical data interfacing software

Care Orchestrator - 00606959053533

Care Orchestrator, Clinical data collection management information system application software
Respironics, Inc.
1.16
In Commercial Distribution

  • 00606959053533 ()
1126366

  • Medical equipment clinical data interfacing software

PULSOX-300i - 00817770020578

Oximeter Sleep Study with Soft Tip Probe and without Software
MAXTEC, LLC
R204P18-003
In Commercial Distribution

  • 00817770020578 ()


  • Pulse oximeter

GoCheck Kids - B430GCKNOK44600

GoCheck Kids stand-alone software version 4.4.60 for the Nokia device.
Gobiquity, Inc.
Nokia 4.4.60
In Commercial Distribution

GCKNOK

  • External ocular measurement camera

Bioness Integrated System (BITS)2.0.5 - 00815962020238

Bioness Integrated Therapy System, Version 2.0, 48" Display with Software
BIONESS INC.
BIT-2048
In Commercial Distribution

  • 00815962020238 ()


  • Perceptual-coordination assistive training device

Bioness Integrated System (BITS)2.0.5 - 00815962020221

Bioness Integrated Therapy System, Version 2.0, 55" Display with Software
BIONESS INC.
BIT-2055
In Commercial Distribution

  • 00815962020221 ()


  • Perceptual-coordination assistive training device

Norav 1200 Series PC-ECG - 07290110254971

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis, including support for NR via USB The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-2
In Commercial Distribution

  • 07290110254971 ()
HASP-SW-K-NH301-4-02

  • Electrocardiographic long-term ambulatory recording analyser

Norav 1200 Series PC-ECG - 07290110255428

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Multi User License (up to 10 User) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-A2
In Commercial Distribution

  • 07290110255428 ()
HASP-SW-K-NEMS-A-02

  • Patient-administration information system application software
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