Patient Monitor Module Cardiac Output

Primary DI
00884838020948
Brand
Patient Monitor Module Cardiac Output
Company
Philips Medizin Systeme Böblingen GmbH
Model
Cardiac Output Parameter Module
Catalog number
862279
Device description
Cardiac Output Parameter Module for use with IntelliVue Patient Monitors. The Cardiac Output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using a technique called thermodilution. Supports either preloaded syringes or flow-through (CO-Set) technique.
Published
2016-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150310000IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015-05-13DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838020948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838020948008848380209488848380209480884838020948

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, cardiac outputA small unit dedicated to the measurement of cardiac output (the volume of blood pumped by the heart per minute) obtained through a pressure transducer/catheter introduced into a blood vessel. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the cardiac output parameter/information measured and provided by this module.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
314101143
Device count
1
Serial number
true

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