FDA.reportPublic FDA data

Vital Sync

Primary DI
10884521762626
Brand
Vital Sync
Company
Covidien LP
Model
EWSSW01
Device description
Vital Sync Early Warning Score Application v1 Software with OUS Support
Published
2018-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSXSoftware, transmission and storage, patient data

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSXSoftware, transmission and storage, patient data

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521762626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452176262610884521762626

GMDN Terms#

Term, Definition table
TermDefinition
Multiparameter physiologic analysis workstationA computerized unit intended to be used with a variety of noninvasive sensors (not included) for the non-continuous measurement of a variety of cardiovascular and pulmonary parameters [e.g., blood pressure, electrocardiography (ECG), SpO2, lung volume, airway resistance]; it might also be intended for additional physiologic analysis [e.g., electromyography (EMG), galvanic skin response (GSR)]. It includes sensor inputs, controls (e.g., touchscreen) and is intended to allow viewing, sharing and storage of the data; it is neither intended for continuous monitoring nor stress exercise monitoring.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18033737712341THD Procto Software SystemTHD SPANSX2022-10-07
58051887042642THD Procto Software SystemTHD SPANSX2022-10-07
08033737713037THD Procto Software SystemTHD SPANSX2021-07-19
18033737712389THD Procto Software SystemTHD SPANSX2021-07-19
00852132007286PatientCare PlatformPREVENTICE TECHNOLOGIES, INC.NSX2021-06-16
00852132007293BodyGuardian ConnectPREVENTICE TECHNOLOGIES, INC.NSX2021-06-16
00852132007309ECG Plug-InPREVENTICE TECHNOLOGIES, INC.NSX2021-06-16
00851831007078Picis Perioperative and Critical CarePicis Clinical Solutions, Inc.NSX2021-03-18
00851831007054Picis Perioperative and Critical Care Picis Clinical Solutions, Inc.NSX2019-11-06
00884838084674IntelliSpace ConsolePhilips Medical Systems HsgNSX2019-03-06
10884521762633Vital SyncCovidien LPNSX2018-09-26
04049957000554Dornier MedTechDornier MedTech GmbHNSX2018-09-13
04049957000561Dornier MedTechDornier MedTech GmbHNSX2018-09-13
04049957000578Dornier MedTechDornier MedTech GmbHNSX2018-09-13
04012030013376seca analytics 115seca GmbH & Co. KGNSX2018-08-15
04012030013383seca analytics 115seca GmbH & Co. KGNSX2018-08-15
04012030013406seca analytics 115seca GmbH & Co. KGNSX2018-08-15
06944413808157NAEdan Instruments, Inc.NSX2017-11-27
00847946019976ChargerZoll Medical CorporationNSX2017-09-06
00884838059313IntelliVue XDS SoftwarePhilips Medizin Systeme Böblingen GmbHNSX2017-08-25
00851831007009Picis Perioperative and Critical CarePicis Clinical Solutions, Inc.NSX2017-04-14
00847946021887ZOLL Code Writer Zoll Medical CorporationNSX2017-03-17
00847946021894ZOLL Code Writer Zoll Medical CorporationNSX2017-03-17
00847946021900RescueNet ePCRZoll Medical CorporationNSX2017-03-17
00847946021917RescueNet ePCRZoll Medical CorporationNSX2017-03-17
00847946021924ZOLL ePCR iOSZoll Medical CorporationNSX2017-03-17
00847946021931ZOLL RescueNet LinkZoll Medical CorporationNSX2017-03-17
00847946021948ZOLL RescueNet LinkZoll Medical CorporationNSX2017-03-17
06944413808126NAEdan Instruments, Inc.NSX2016-12-03
06944413808140NAEdan Instruments, Inc.NSX2016-12-03