FDA.reportPublic FDA data

FetaLink+®

Primary DI
00853023006142
Brand
FetaLink+®
Company
Cerner Corporation
Model
FetaLink+4
Published
2017-01-16
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
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121758000CERNER FETALINK+(VERSION1.0)Cerner Corp.2012-10-09HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853023006142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853023006142008530230061428530230061420853023006142

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrics information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of obstetrical services and facilities. It is typically supplied for installation into a dedicated obstetrics information system or existing mainframe or decentralized computers/networks and is used in a labour ward/maternity unit and allows the electronic entry of a patient?s details of labour for viewing at different locations.

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
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
00853023006098Oracle Health Blood BankPathNet Blood Bank Transfusion 20122016-08-05

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06944413807112Remote Event MarkerEdan Instruments, Inc.HGM2025-11-29
00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
00198953043271CareIntellect PerinatalGe Medical Systems Information Technologies, Inc.HGM2025-11-21