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 | 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 |
| DRS | Transducer, Blood-Pressure, Extravascular | Cardiovascular | 870.2850 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | 870.2300 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
| HGL | Transducer, Ultrasonic, Obstetric | Obstetrics/Gynecology | 884.2960 | 2 |
| DSF | Recorder, Paper Chart | Cardiovascular | 870.2810 | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | Obstetrics/Gynecology | 884.2720 | 2 |
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
| HFN | Transducer, Pressure, Intrauterine | Obstetrics/Gynecology | 884.2700 | 2 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Cardiovascular | 870.2780 | 2 |
| MSX | System, Network And Communication, Physiological Monitors | Cardiovascular | 870.2300 | 2 |
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | 870.1025 | 2 |
| DSJ | Alarm, Blood-Pressure | Cardiovascular | 870.1100 | 2 |
| DXQ | Blood Pressure Cuff | Cardiovascular | 870.1120 | 2 |
| DSK | Computer, Blood-Pressure | Cardiovascular | 870.1110 | 2 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | Cardiovascular | 870.1435 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838093195 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [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