FDA.report

McKesson Cardiology Hemo

Primary DI
80010939050010
Company
MCKESSON TECHNOLOGIES INC.
Model
13.2.1
Published
2016-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
962049362
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
80010939050010PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
80010939050010PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DQKComputer, Diagnostic, Programmable2Cardiovascular870.1425NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Cardiac catheterization laboratory computerA dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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80010939020044McKesson Radiology12.2.32017-10-13
80010939120010Conserus Enterprise Viewer1.12016-08-26
80010939120027Conserus Enterprise Viewer2.02017-04-28
80010939130019Conserus Enterprise Viewer Mobile1.12016-08-26
80010939040028McKesson Cardiology ECG Management14.02017-03-09
80010939050027McKesson Cardiology Hemo14.02017-03-09
80010939070025McKesson Cardiology14.02017-03-09
80010939010014McKesson Anesthesia Care15.22016-06-10
80010939040011McKesson Cardiology ECG Management13.2.12016-08-30
80010939070018McKesson Cardiology™13.2.12016-08-30

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