Avalon ECG/IUP Transducer

Basic Information

• Brand Name: Avalon ECG/IUP Transducer
• Primary DI: 00884838093201
• Version / Model: Avalon ECG/IUP Transducer
• Catalog Number: 867247
• 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: 2021-03-08
• Public Version: 4
• Public Version Date: 2023-05-05
• Public Version Status: Update
• Public Device Record Key: 02c1b948-c916-4bb6-a7ba-296959f326e7

Device Description

The device is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates

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: Yes
• 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
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	884.2740	2
DQA	Oximeter	Cardiovascular	870.2700	2
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	870.2060	2
DXQ	Blood Pressure Cuff	Cardiovascular	870.1120	2
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	870.2850	2
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	870.2300	2
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	870.2780	2
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	870.2900	2
DSF	Recorder, Paper Chart	Cardiovascular	870.2810	1
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	870.1025	2
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	870.1435	2
HFM	Monitor, Uterine Contraction, External (For Use In Clinic)	Obstetrics/Gynecology	884.2720	2
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	870.2300	2
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2
DSJ	Alarm, Blood-Pressure	Cardiovascular	870.1100	2
HFN	Transducer, Pressure, Intrauterine	Obstetrics/Gynecology	884.2700	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2
DSK	Computer, Blood-Pressure	Cardiovascular	870.1110	2
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	884.2960	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36553	Patient monitoring system module, multifunction	A small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. 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 which then operates as a mainframe computer displaying the various parameters/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	00884838093201	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 16 – 107.5 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity