FDA.reportPublic FDA data

CARESCAPE Central Station

Primary DI
00840682109666
Brand
CARESCAPE Central Station
Company
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Model
V2 Integrated MAI 700
Device description
CARESCAPE CENTRAL STATION V2 MAI 700 ATO MODEL
Published
2017-02-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
DSIDETECTOR AND ALARM, ARRHYTHMIA
DXJDISPLAY, CATHODE-RAY TUBE, MEDICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2
DXJDisplay, Cathode-Ray Tube, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162012000CARESCAPE Central Station V2GE Healthcare2016-09-15DXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682109666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682109666008406821096668406821096660840682109666

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)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure500 KiloPascal1075 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
784985108
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278620873MAC72119091-0012026-03-31
00840682122504N/A420915-0692016-12-14
00840682122528N/A420915-0112016-12-13
00195278507037Mac-LabAltiX2300000-0032026-03-26
00195278507044CardioLabAltiX2300000-0042022-05-01
00195278507051ComboLabAltiX2300000-0052022-05-01
00195278507525MLCL Client SoftwareAltiX58896052022-05-01
00195278516015MLCL UpgradeAltiX58965972022-05-01
00195278330413Portrait CVA01CVA0158637212023-09-01
00195278341129Portrait CSS01CSS0158708572023-09-01
00840682104814NA2017098-0072016-07-22
00840682104845NA2017098-0032016-07-22
00840682104852NA2017098-0012016-07-22
00840682104869NA2017098-0052016-07-22
00840682109260CARESCAPETelemetry Server V42016-06-10
00840682104784N/APatient Data Module2016-05-27
00840682108775CARESCAPETelemetry Server v4 upgrade2016-06-10
00840682108799ApexPro600 MHz Receiver2016-06-10
00840682108928ApexProCH Transmitter2016-06-10
00840682109024ApexProFH Transceiver2016-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
10193489385625Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXJ2023-06-08
10841522129797TruLinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2023-05-16
10841522129803TruLinkSPACELABS HEALTHCARE (WASHINGTON), INCDSI2023-05-16
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
08714729996545AVVIGO™ Guidance SystemBOSTON SCIENTIFIC CORPORATIONDQK2020-08-17
08714729996552AVVIGO™ Guidance SystemBOSTON SCIENTIFIC CORPORATIONDQK2020-08-17
08437011759092Nuubo SystemSMART SOLUTIONS TECHNOLOGIES SLDQK2019-11-20
10841522127212LifecardSPACELABS HEALTHCARE (WASHINGTON), INCDQK2019-05-28
10841522127229EVO RecorderSPACELABS HEALTHCARE (WASHINGTON), INCDQK2019-05-28
10841522127069XhibitSPACELABS HEALTHCARE (WASHINGTON), INCDSI2019-04-01
10841522125829Pathfinder SLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2019-02-27
10841522125836Pathfinder SLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2019-02-27
10841522125843Pathfinder SLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2019-02-27
10841522125850Pathfinder SLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2019-02-27
10841522125867Pathfinder SLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2019-02-27
10841522125874Pathfinder SLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2019-02-27
10841522125881Pathfinder SLSPACELABS HEALTHCARE (WASHINGTON), INCDQK2019-02-27