FDA UDI In Commercial Distribution 🇺🇸 United States

Avalon Ultrasound Transducer

DI: 00884838093195 · Model: Avalon Ultrasound Transducer · Philips Medizin Systeme Böblingen GmbH
Product Codes
20
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Avalon Ultrasound Transducer
Primary DI
00884838093195
Version / Model
Avalon Ultrasound Transducer
Catalog Number
867246
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
5
Public Version Date
2023-05-05
Public Version Status
Update
Public Device Record Key
70d13bf4-a1cc-458b-8b00-c563ffd15028

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)
No
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
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

GMDN Terms

Code Name
41917 Foetal Doppler system probe

Identifiers

Type ID
Primary 00884838093195

Customer Contacts

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