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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Platelet PGDprime Sample Pipettes for adding the platelet sample to the processing tube.
Verax Biomedical Incorporated
P01230
In Commercial Distribution

  • 10850046056250 ()
  • 10850046056069 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Negative Control for quality control testing of the Platelet PGDprime Test System.
Verax Biomedical Incorporated
P01113
In Commercial Distribution

  • 10850046056052 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Positive Control for quality control testing of the Platelet PGDprime Test System.
Verax Biomedical Incorporated
P01412
In Commercial Distribution

  • 10850046056045 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Reagent 2 required for processing platelet sample prior to testing with the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01214
In Commercial Distribution

  • 10850046056038 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Reagent 1B required for processing platelet sample prior to testing with the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01413
In Commercial Distribution

  • 10850046056021 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Reagent 1A required to process the platelet sample prior to testing with the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01111
In Commercial Distribution

  • 10850046056014 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Platelet PGDprime Test single device pouch
Verax Biomedical Incorporated
T.00001186E
In Commercial Distribution

  • 10850046056007 ()
  • 10850046056106 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
Widex ToneLink App iOS
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702958 ()
5 300 0016 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Widex MOMENT App iOS
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930313 ()
5 300 0021 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
DreamMapper App iOS (APAC)
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044111 ()
1127959

  • Self-care monitoring/reporting software
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