DEVICE: Avalon ECG/IUP Transducer (00884838093201)
Device Identifier (DI) Information
Avalon ECG/IUP Transducer
Avalon ECG/IUP Transducer
In Commercial Distribution
867247
Philips Medizin Systeme Böblingen GmbH
Avalon ECG/IUP Transducer
In Commercial Distribution
867247
Philips Medizin Systeme Böblingen GmbH
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
| MR Unsafe | |
| No | |
| Yes | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HGM | System, Monitoring, Perinatal |
| DQA | Oximeter |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal |
| DXQ | Blood Pressure Cuff |
| DRS | Transducer, Blood-Pressure, Extravascular |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) |
| DSF | Recorder, Paper Chart |
| DSI | Detector And Alarm, Arrhythmia |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) |
| MSX | System, Network And Communication, Physiological Monitors |
| FLL | Thermometer, Electronic, Clinical |
| DSJ | Alarm, Blood-Pressure |
| HFN | Transducer, Pressure, Intrauterine |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| DSK | Computer, Blood-Pressure |
| HGL | Transducer, Ultrasonic, Obstetric |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between -20 and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure: between 57 and 106 KiloPascal |
| Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
02c1b948-c916-4bb6-a7ba-296959f326e7
October 31, 2024
5
March 08, 2021
October 31, 2024
5
March 08, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(999)999-9999
xx@xx.xx
xx@xx.xx