FDA.reportPublic FDA data

Change Healthcare Cardiology Hemo

Primary DI
17540262100136
Brand
Change Healthcare Cardiology Hemo
Company
Change Healthcare Canada Company
Model
15.1.1
Published
2025-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131497000MCKESSON CARDIOLOGY HEMOMckesson Israel , Ltd.2013-12-05MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540262100136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1754026210013617540262100136

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246576391
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17540262200126Change Healthcare Stratus Imaging Diagnostic Viewer2.122026-10-05
17540262200102Change Healthcare Stratus Imaging Diagnostic Viewer2.102026-07-22
17540262200096Change Healthcare Stratus Imaging Diagnostic Viewer2.92026-05-27
17540262020014McKesson Radiology12.32018-02-20
17540262140262Change Healthcare Stratus Imaging Viewer1.0.252026-04-16
17540262200010Stratus Imaging Diagnostic Viewer2.12025-10-27
17540262200034Change Healthcare Stratus Imaging Diagnostic Viewer2.32025-10-27
17540262140255Change Healthcare Stratus Imaging Viewer1.0.242026-03-19
17540262140248Change Healthcare Stratus Imaging Viewer1.0.232026-01-29
17540262140231Change Healthcare Stratus Imaging Viewer1.0.222025-11-20
17540262160185Change Healthcare Stratus Imaging PACS1.7.02025-09-15
17540262160161Change Healthcare Stratus Imaging PACS1.4.72024-12-10
17540262130225Change Healthcare Stratus Imaging Viewer1.0.212025-08-05
17540262010060Change Healthcare Enterprise Viewer14.2.12025-06-26
17540262130218Change Healthcare Stratus Imaging Viewer1.0.202025-06-23
17540262030068Change Healthcare Radiology Solutions14.2.22025-05-16
17540262180053Change Healthcare Mammography Plus14.2.22025-05-16
17540262130201Change Healthcare Stratus Imaging Viewer1.0.192025-04-03
17540262160178Change Healthcare Stratus Imaging PACS1.4.82025-04-03
17540262130195Change Healthcare Stratus Imaging Viewer1.0.182024-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841709121746MidmarkMIDMARK CORPORATIONMWI2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONMWI2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONMWI2026-10-30
00841709121777MidmarkMIDMARK CORPORATIONMWI2026-10-30
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-10-28
08800159500060S-Patch CardioAIWellysis Corp.DQK2026-10-27
00860009793538STAR ArtemisRhythm AI Inc.DQK2026-10-26
00195278840202MACGe Medical Systems Information Technologies, Inc.DQK2026-10-13
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQK2026-10-04
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-09-20
00885403523512HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403523536HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403533764Smart Pressure ControllerBecton, Dickinson And CompanyDQK2026-09-18
00885403533771Smart Pressure Controller Accessory KitBecton, Dickinson And CompanyDQK2026-09-18
00199150062911N/AMEDTRONIC, INC.DQK2026-09-04
00198953213063ComboLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213087CardioLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
00885403523437HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyDQK2026-08-06