FDA.reportPublic FDA data

Vital Sync

Primary DI
10884521762633
Brand
Vital Sync
Company
Covidien LP
Model
WRSBTSW01
Device description
Vital Sync Weaning Readiness and Spontaneous Breathing Trial Monitoring Application v1 Software with OUS Support
Published
2018-09-26
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
10884521762633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452176263310884521762633

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
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

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Primary DI, Brand, Company table
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18033737712389THD Procto Software SystemTHD SPANSX2021-07-19
00852132007286PatientCare PlatformPREVENTICE TECHNOLOGIES, INC.NSX2021-06-16
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00884838084674IntelliSpace ConsolePhilips Medical Systems HsgNSX2019-03-06
10884521762626Vital SyncCovidien LPNSX2018-09-20
04049957000554Dornier MedTechDornier MedTech GmbHNSX2018-09-13
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04012030013376seca analytics 115seca GmbH & Co. KGNSX2018-08-15
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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