FDA.reportPublic FDA data

Sentinel

Primary DI
10841522103452
Brand
Sentinel
Company
SPACELABS HEALTHCARE (WASHINGTON), INC
Model
98200
Catalog number
10.0.1
Device description
Cardiology Information Management System
Published
2017-01-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841522103452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084152210345210841522103452

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac stress exercise monitoring systemAn assembly of devices comprising a stress exercise monitoring system designed to record electrocardiograph (ECG) signals from electrodes placed on a patient's limbs and chest while the patient engages in varying degrees of exercise on a device or system of a predetermined kind, e.g., an ergometer. The system will typically analyse the recorded data, display results, monitor various functions, provide control of the workload, and give printouts, providing the clinician with a complete representation of the electrical activity of the heart, including heart rate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Regulatory Flags#

DUNS number
145581588
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841522105067UltraliteUltralite90217A-12016-10-21
10841522103292Spacelabs Healthcare98400N/A2016-09-23
10841522125102PathfinderSLPathfinder SL040-1757-002018-06-19
10841522128851Eclipse ProEclipse Pro987002023-10-09
10841522100208Spacelabs Healthcare90499904992016-10-10
10841522118173Spacelabs HealthcareDATUM130132232017-01-03
10841522118258Spacelabs HealthcareDATUM130222572017-01-03
10841522118265Spacelabs HealthcareDATUM130232182017-01-03
10841522118326Spacelabs HealthcareDATUM130612182017-01-03
10841522118357Spacelabs HealthcareDATUM130622182017-01-03
10841522118371Spacelabs HealthcareDATUM130622522017-01-03
10841522118401Spacelabs HealthcareDATUM130632182017-01-03
10841522118494Spacelabs HealthcareDATUM130121182016-12-29
10841522118562Spacelabs HealthcareDATUM130131182016-12-29
10841522118579Spacelabs HealthcareDATUM130131292016-12-29
10841522118593Spacelabs HealthcareDATUM130211182016-12-29
10841522118616Spacelabs HealthcareDATUM130221182016-12-29
10841522118685Spacelabs HealthcareDATUM130611182016-12-29
10841522118722Spacelabs HealthcareDATUM130613302016-12-29
10841522118753Spacelabs HealthcareDATUM130621182016-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDDXH2025-02-07
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
08800069700178AT-PatchATsens Co., Ltd.DQK2022-12-23
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982876MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
15099169413303ECGVITALOGRAPH (IRELAND) LIMITEDDXH2021-07-09
15099169413334ECGVITALOGRAPH (IRELAND) LIMITEDDXH2021-07-09
15099169413037ECGVITALOGRAPH (IRELAND) LIMITEDDXH2020-09-30
00843152100002IOPS Mobile CartCenterline Biomedical, Inc.DQK2020-09-18
08714729996545AVVIGO™ Guidance SystemBOSTON SCIENTIFIC CORPORATIONDQK2020-08-17
08714729996552AVVIGO™ Guidance SystemBOSTON SCIENTIFIC CORPORATIONDQK2020-08-17
08437011759092Nuubo SystemSMART SOLUTIONS TECHNOLOGIES SLDQK2019-11-20
17540262100037Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2019-08-26
10856602005236NAPROTEUS DIGITAL HEALTH, INC.DXH2019-07-12