FDA.reportPublic FDA data

Oracle Health Patient Observer

Primary DI
00853023006203
Brand
Oracle Health Patient Observer
Company
Cerner Corporation
Model
CPO-SP4
Catalog number
CFG_PATOBSRVR
Published
2019-09-30
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
KMIMonitor, Bed Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMIMonitor, Bed PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853023006203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853023006203008530230062038530230062030853023006203

GMDN Terms#

Term, Definition table
TermDefinition
Inpatient motion surveillance softwareA software program designed to be used in a healthcare setting to track the movements of an inpatient, typically a patient in a hospital side/isolation room or nursing home, to detect high-risk behaviour (e.g., bedridden patient bed vacation attempt, fall risk) and automatically send alert notifications to healthcare staff via a central monitoring station or nurse call system in response. It is used in conjunction with video surveillance motion sensors/cameras and is intended to analyse patient motion with respect to predetermined motion threshold references.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042410688
Device count
1
Premarket exempt
true

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
00853023006234Oracle Health Patient ObserverCPO-SP6CFG_PATOBSRVR2019-09-30
00853023006029Soarian Device ConnectCernerSDCv2.02016-07-16
00853023006067Oracle Health Blood BankPathNet Blood Bank Transfusion20152016-08-05
00853023006098Oracle Health Blood BankPathNet Blood Bank Transfusion 20122016-08-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840828195102FM UNDER-MATTERSS KIT-CORDEDCURBELL MEDICAL PRODUCTS, INC.KMI2025-09-10
00850064210163Central Hub CMSSibel Health Inc.KMI2025-03-27
00850064210194Central Hub SpeakerSibel Health Inc.KMI2025-03-27
00850064210002ANNE Chest Sensor KitSibel Health Inc.KMI2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.KMI2025-03-26
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00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.KMI2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.KMI2025-03-26
00850064210132ANNE View Patient MonitorSibel Health Inc.KMI2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.KMI2025-03-26
10080196373239MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
00080196750118MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-12-25
10193489001921MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-11-28
10193489036633MEDLINEMEDLINE INDUSTRIES, INC.KMI2024-10-25
00023601033048CAREX HEALTH BRANDSDrive Devilbiss HealthcareKMI2024-09-30
00023601033055CAREX HEALTH BRANDSDrive Devilbiss HealthcareKMI2024-09-30
00840828192149UNI BED SHORT-TERM-SNAP PADCURBELL MEDICAL PRODUCTS, INC.KMI2024-07-19
00618125191406PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191413PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191420PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191437PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191444PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191451PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191468PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191499PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191505PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191512PoseyTIDI PRODUCTS, LLCKMI2024-05-03
00618125191529PoseyTIDI PRODUCTS, LLCKMI2024-05-03