DEVICE: Avalon Ultrasound Transducer (00884838093195)
Device Identifier (DI) Information
Avalon Ultrasound Transducer
Avalon Ultrasound Transducer
In Commercial Distribution
867246
Philips Medizin Systeme Böblingen GmbH
Avalon Ultrasound Transducer
In Commercial Distribution
867246
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 | |
| No | |
| 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? |
|---|---|---|---|---|
| 41917 | Foetal Doppler system probe |
A hand-operated component of a foetal Doppler system intended to be placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.
|
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 |
| DRS | Transducer, Blood-Pressure, Extravascular |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) |
| HGL | Transducer, Ultrasonic, Obstetric |
| DSF | Recorder, Paper Chart |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) |
| FLL | Thermometer, Electronic, Clinical |
| HFN | Transducer, Pressure, Intrauterine |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| MSX | System, Network And Communication, Physiological Monitors |
| DSI | Detector And Alarm, Arrhythmia |
| DSJ | Alarm, Blood-Pressure |
| DXQ | Blood Pressure Cuff |
| DSK | Computer, Blood-Pressure |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
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
70d13bf4-a1cc-458b-8b00-c563ffd15028
October 31, 2024
6
March 08, 2021
October 31, 2024
6
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