FDA.reportPublic FDA data

Cerner CareAware iBus

Primary DI
00853023006012
Brand
Cerner CareAware iBus
Company
Cerner Corporation
Model
CareAwareiBus6
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093134000CERNER CAREAWARE IBUSCerner Corp.2009-11-27DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853023006012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853023006012008530230060128530230060120853023006012

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment clinical data interfacing softwareAn application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042410688
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017753136FetaLink+FL+Android12025-07-03
00850017753129FetaLinkFetaLink 200100000852025-04-21
00853023006227Cerner FetaLinkFetaLink2002019-05-01
00853023006043FetaLink®FetaLink20142016-08-05
00853023006210FetaLink+FetaLink+62019-05-01
00853023006050FetaLink+®FetaLink+32016-08-05
00853023006081FetaLink®FetaLink20132016-08-05
00853023006142FetaLink+®FetaLink+42017-01-16
00853023006166FetaLink+FetaLink+52018-03-09
00853023006111Cerner CareAware Event ManagementCareAwareEventManagement52016-09-24
00853023006135Cerner CareAware Event ManagementCareAwareEventManagement62016-09-24
00850017753112FetaLink+FL+72024-05-24
00853023006180Cerner Motion HealthMotionHealth2016.222017-07-27
00850017753037Oracle Health Patient ObserverCPO-SP7CFG_PATOBSRVR2020-12-14
00853023006241Oracle Health Patient ObserverCPO-I415CFG_PATOBSRVR2020-01-31
00853023006197Oracle Patient ObserverCPO-SPCFG_PATOBSRVR2019-09-30
00853023006203Oracle Health Patient ObserverCPO-SP4CFG_PATOBSRVR2019-09-30
00853023006234Oracle Health Patient ObserverCPO-SP6CFG_PATOBSRVR2019-09-30
00853023006029Soarian Device ConnectCernerSDCv2.02016-07-16
00853023006067Oracle Health Blood BankPathNet Blood Bank Transfusion20152016-08-05

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Primary DI, Brand, Company table
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