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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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LIFENET Adapter 32-BIT - 00883873903438

LIFENET Adapter 32-BIT RELEASE 5.3.3
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903438 ()
21340-000794

  • Emergency/ambulatory healthcare software

LIFENET SERVER - 00883873903278

LIFENET SERVER
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873903278 ()
21340-000796

  • Emergency/ambulatory healthcare software

LIFENET ALERT 32-BIT - 00883873901878

LIFENET ALERT 32-BIT
PHYSIO-CONTROL, INC.
21340
Not in Commercial Distribution

  • 00883873901878 ()
21340-000800

  • Emergency/ambulatory healthcare software

Invivo - 00884838066991

UroNAV 1.x to 2.0 Upgrade
Philips DS North America LLC
784011
In Commercial Distribution

  • 00884838066991 ()


  • Stereotactic system application software

Oticon - 05707131378774

GENIE 2, 2020.1 VA
Oticon A/S
214208
In Commercial Distribution

  • 05707131378774 ()


  • Audiometric/hearing device software

Oticon - 05707131378767

AUDIGYFIT 2, 2020.1 AGX HEARING
Oticon A/S
214207
In Commercial Distribution

  • 05707131378767 ()


  • Audiometric/hearing device software

Oticon - 05707131378712

GENIE 2, 2020.1 OTICON
Oticon A/S
214202
In Commercial Distribution

  • 05707131378712 ()


  • Audiometric/hearing device software

Canvas Dx - 00860007260605

Canvas Dx is a prescription diagnostic aid to healthcare professionals (HCP) considering the diagnosis of Autism Spectrum Disorder (ASD) in patients 18 months through 72 months of age at risk for developmental delay. The patient’s caregiver uses a smartphone application (“App”) to fill out a caregiver questionnaire and to make video recordings of behavior at home, and then the physician fills out a medical questionnaire online. The results are made available to the physician.
Cognoa, Inc.
1.3.0
In Commercial Distribution

  • 00860007260605 ()


  • Neurodevelopmental disorder interpretive software

REMI - 00860005388158

REMI-Cloud
Epitel, Inc.
2.3
Not in Commercial Distribution

  • 00860005388158 ()


  • Bioelectrical signal analysis software

REMI - 00860005388110

REMI EEG Monitoring Software (Healthcare Facility module) - v. 2.x.x.x
Epitel, Inc.
2.3.0
In Commercial Distribution

  • 00860005388110 ()


  • Bioelectrical signal analysis software
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