Patient Monitor Module Cardiac Output

Basic Information

• Brand Name: Patient Monitor Module Cardiac Output
• Primary DI: 00884838020948
• Version / Model: Cardiac Output Parameter Module
• Catalog Number: 862279
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Labeler DUNS: 314101143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-02
• Public Version: 7
• Public Version Date: 2023-05-05
• Public Version Status: Update
• Public Device Record Key: 8f2397da-3f31-4be9-b28c-b90c6faecb79

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRT	MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36561	Patient monitoring system module, cardiac output	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838020948	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity