CERNER CORPORATION

CERNER CORPORATION

Address:8779 Hillcrest Rd,Kansas City,MO,64138,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Monitoring, Perinatal (HGM) (3) Software, Blood Bank, Stand Alone Products (MMH) (2) System, Image Processing, Radiological (LLZ) (2) Monitor, Bed Patient (KMI) (1) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (1) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (1)

Premarket Exempt

No Yes

Clear

Cerner Patient Observer - 00850017753037 Catalog Number : CFG_PATOBSRVR

Device Class : 1

Duns Number: 042410688

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : Yes

Device Count : 1

Cerner CareAware iBus - 00853023006012 Catalog Number :

Device Class : 2

Duns Number: 042410688

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

Soarian Device Connect - 00853023006029 Catalog Number :

Device Class : 2

Duns Number: 042410688

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Cerner SkyVue® - 00853023006036 Catalog Number :

Device Class : 2

Duns Number: 042410688

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

FetaLink® - 00853023006043 Catalog Number :

Device Class : 2

Duns Number: 042410688

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

FetaLink+® - 00853023006050 Catalog Number :

Device Class : 2

Duns Number: 042410688

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

PathNet® Blood Bank Transfusion - 00853023006067 Catalog Number :

Device Class : 2

Duns Number: 042410688

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

Cerner SkyVue® - 00853023006074 Catalog Number :

Device Class : 2

Duns Number: 042410688

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

FetaLink® - 00853023006081 Catalog Number :

Device Class : 2

Duns Number: 042410688

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

PathNet® Blood Bank Transfusion - 00853023006098 Catalog Number :

Device Class : 2

Duns Number: 042410688

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

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