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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Lifelines iEEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions. The two main components of Lifelines iEEG are iEEG Centrum and iEEC Review.
Kvikna Medical ehf.
KSW2060
Not in Commercial Distribution

  • 05694110063069 ()


  • Bioelectrical signal analysis software
Lifelines iEEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions. The two main components of Lifelines iEEG are iEEG Centrum and iEEC Review.
Kvikna Medical ehf.
KSW2050
Not in Commercial Distribution

  • 05694110063052 ()


  • Bioelectrical signal analysis software
No Description
ICU MEDICAL, INC.
22-4095-0204-25
In Commercial Distribution

  • 15019517088632 ()


  • Infusion pump medication-dosage application software
The Q21 is a 19 channel EEG amplifier with a low noise floor of 0.25 microvolts peak to peak from 0.1 to 10.0Hz, meaning that you can record brain wave data without worrying about noise contamination. On top of our low-noise design, the Q21 is a non-multiplexed, multi-channel readout amp, minimizing slew for the most accurate whole brain imaging, and giving you the exact readout of your EEG recordings, with no loss of data or smoothing.
NEUROFIELD, INC.
169
In Commercial Distribution

  • 00860410000379 ()


  • Multiple physiological signal amplifier
Top and Bottom Aligners
ARCADLAB
Clear Orthodontic Aligners
In Commercial Distribution

  • 00860011071921 ()


  • Orthodontic aligner auxiliary attachment kit
Orthex P&C Software v1.2
ORTHOPEDIATRICS CORP.
ORTHEXRPS
In Commercial Distribution

  • 00841132179772 ()
ORTHEXRPS

  • External orthopaedic fixation frame calculation software
Orthex P&C Software v2
ORTHOPEDIATRICS CORP.
ORTHEXSW
In Commercial Distribution

  • 00840194428002 ()
ORTHEXSW

  • External orthopaedic fixation frame calculation software
Alaris Systems Manager v12-12.5.1
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403960123 ()


  • Infusion pump medication-dosage application software
Alaris Systems Maintenance
CAREFUSION 303, INC.
8975
Not in Commercial Distribution

  • 10885403897511 ()


  • Infusion pump medication-dosage application software
Alaris Guardrails Editor 10.X
CAREFUSION 303, INC.
8961
Not in Commercial Distribution

  • 10885403896118 ()


  • Infusion pump medication-dosage application software
Alaris Systems Manager v12.5.2
CAREFUSION 303, INC.
9601
In Commercial Distribution

  • 10885403519666 ()


  • Infusion pump medication-dosage application software
Calculation Services 1.X
CAREFUSION 303, INC.
1.X
In Commercial Distribution

  • 10885403510489 ()


  • Infusion pump medication-dosage application software
Infusion Adapter (v1.7.X)
CAREFUSION 303, INC.
Infusion Adapter
In Commercial Distribution

  • 10885403510472 ()


  • Infusion pump medication-dosage application software
Electrode Clip, Limb
NIHON KOHDEN AMERICA, INC.
NC-143E
In Commercial Distribution

  • 10841983103084 ()
  • 00841983103087 ()
NC-143E

  • Electrocardiograph, professional, multichannel
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOSMART110 ()


  • Home pharmaceutical management support software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOSMART100 ()


  • Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOINSIGHTS110 ()


  • Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOINSIGHTS100 ()


  • Home pharmaceutical management support software
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-07
In Commercial Distribution

  • 00811505030450 ()
IMS

  • Infusion pump medication-dosage application software
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-06
In Commercial Distribution

  • 00811505030443 ()
IMS

  • Infusion pump medication-dosage application software
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-05
In Commercial Distribution

  • 00811505030399 ()
IMS

  • Infusion pump medication-dosage application software
Infusion Management System (IMS), version 4.0.0
Fresenius Kabi AG
4.0.0
In Commercial Distribution

  • 00811505030351 ()
IMS-0700

  • Infusion pump medication-dosage application software
Infusion Management System (IMS) Version 3.0.0
Fresenius Kabi AG
3.0.0
In Commercial Distribution

  • 00811505030177 ()
IMS-0600

  • Infusion pump medication-dosage application software
Infusion Management System (IMS), version 2.0
Fresenius Kabi AG
2.0
Not in Commercial Distribution

  • 00811505030016 ()
IMS-0500

  • Infusion pump medication-dosage application software
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-05
Not in Commercial Distribution

  • 00811050530399 ()
IMS

  • Infusion pump medication-dosage application software
TouchChat HD w/ WordPower App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021015 ()
18626

  • Voice synthesizer/digitizer
Electrode Clip, Limb, 4/BX
NIHON KOHDEN CORPORATION
NC-143E
In Commercial Distribution

  • 04931921871355 ()
NC-143E

  • Electrocardiograph, professional, multichannel
EEG trend program
NIHON KOHDEN CORPORATION
QP-160AK
In Commercial Distribution

  • 04931921112991 ()
QP-160AK

  • Electroencephalograph
Photic stimulator control unit
NIHON KOHDEN CORPORATION
LS-120AJ
In Commercial Distribution

  • 04931921112946 ()
LS-120AJ

  • Electroencephalograph
CART, COMPACT TYPE, EEG-1200A
NIHON KOHDEN CORPORATION
KE-122A
In Commercial Distribution

  • 04931921112885 ()
KE-122A

  • Instrument trolley
ADAPTER DUAL MOUNT, PHOTIC / INPUT
NIHON KOHDEN CORPORATION
DI-120A
In Commercial Distribution

  • 04931921112724 ()
DI-120A

  • Instrument trolley
Neurofax Electroencephalograph
NIHON KOHDEN CORPORATION
EEG-1200A
In Commercial Distribution

  • 04931921110904 ()
EEG-1200A

  • Electroencephalograph
Flat Pack Mini Expansion, Channel 193-256
NIHON KOHDEN CORPORATION
JE-228AK
In Commercial Distribution

  • 04931921108154 ()
JE-228AK

  • Electroencephalograph
Analog output unit
NIHON KOHDEN CORPORATION
QD-120A
In Commercial Distribution

  • 04931921107485 ()
QD-120A

  • Electroencephalograph
Input box converter, EEG-1200A
NIHON KOHDEN CORPORATION
QI-122A
In Commercial Distribution

  • 04931921104170 ()
QI-122A

  • Electroencephalograph
Neurofax Electroencephalograph
NIHON KOHDEN CORPORATION
EEG-1260A
In Commercial Distribution

  • 04931921009161 ()
EEG-1260A

  • Electroencephalograph
Cart, Compact type, used with EEG-1200A, works with standard and optional accessories
NIHON KOHDEN CORPORATION
KE-122A-01
In Commercial Distribution

  • 04931921007730 ()
KE-122A-01

  • Instrument trolley
Cart, used with EEG-1200A, works with standard and optional accessories
NIHON KOHDEN CORPORATION
KD-029A-01
In Commercial Distribution

  • 04931921007723 ()
KD-029A-01

  • Instrument trolley
Flash lamp assembly, Round shape
NIHON KOHDEN CORPORATION
LS-706A-01
In Commercial Distribution

  • 04931921007716 ()
LS-706A-01

  • Electroencephalograph
Bundled cable for JE-120A-256
NIHON KOHDEN CORPORATION
AAA-17041
In Commercial Distribution

  • 04931921004357 ()


  • Electroencephalograph
Vigilant Master Med is a component of the Vigilant Software Suite. Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with Adults, Pediatrics, and Neonates. It is intended to create, customize, and manage drug library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices which may reduce the risk of drug administration errors. It enhances safety by preventing infusion errors with the use of Dose Error Reduction System (DERS) in combination with the infusion devices.
Fresenius Kabi AG
ZK288122
In Commercial Distribution

  • 04052682044106 ()
ZK288122

  • Infusion pump medication-dosage application software
ABBOTT PRISM Director Version 2.1
ABBOTT LABORATORIES
3R97-02
Not in Commercial Distribution

  • 00380740138400 ()
03R9702

  • Laboratory instrument/analyser application software IVD
ABBOTT PRISM Director Version 2.0
ABBOTT LABORATORIES
3R97-01
Not in Commercial Distribution

  • 00380740138394 ()
03R9701

  • Laboratory instrument/analyser application software IVD
Hearing Aid Feature watchOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095074 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature macOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095067 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature AirPods Pro 2 Firmware (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149931 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear
MOUNT
BECTON, DICKINSON AND COMPANY
516750
In Commercial Distribution

  • 60382905167500 ()
  • 00382905167508 ()
516750

  • Intravenous injection automated detection/documentation system processor/transmitter
KIT GATEWAY
BECTON, DICKINSON AND COMPANY
516706
In Commercial Distribution

  • 60382905167067 ()
  • 00382905167065 ()
516706

  • Anaesthesia information system application software
KIT TABLET
BECTON, DICKINSON AND COMPANY
516704
In Commercial Distribution

  • 00382905167041 ()
516704

  • Intravenous injection automated detection/documentation system computer
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