FDA.reportPublic FDA data

EarlySense® Central Display Unit

Primary DI
07290016169140
Brand
EarlySense® Central Display Unit
Company
EARLYSENSE LTD
Model
N/A
Catalog number
AME-002500 US
Published
2017-06-16
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
MSXSystem,Network And Communication,Physiological Monitors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151006000EarlySense Central Display Station (CDS)Earlysense, Ltd.2015-08-31MSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016169140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016169140072900161691407290016169140

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system central station monitorA mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649822657
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016169102EarlySense® InSight™N/AAME-01340-02 US2017-06-16
07290016169393EarlySense® InSight™Insight at HomeAME-020212021-07-07
07290016169089EarlySense® Bedside UnitN/AAME-00900 US2017-06-16
17290016169109EarlySense® InSight™N/AAME-01340-02 US2017-06-16
07290016169232Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®AME-00202 HR USHill-Rom PN 2008982018-07-29
07290016169249EarlySense® BEX SensorAME-01610 US2018-07-29
17290016169239Hill-Rom® Heart and Respiration Rate Monitoring SyAME-00202 HR USHill-Rom PN 2008982018-07-29
17290016169246EarlySense® BEX SensorAME-01610 US2018-07-29
07290016169010EarlySense® Contact-Free SensorN/AAME-00200 US2017-06-15
17290016169017EarlySense® Contact-Free SensorN/AAME-00200 US2017-06-15
07290016169065EarlySense® Chair SensorN/AAME-00271 US2017-06-15

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