FDA UDI
In Commercial Distribution
🇺🇸 United States
Avalon Toco+ Transducer
DI: 00884838093225
·
Model: Avalon Toco+ Transducer
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
20
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Avalon Toco+ Transducer
- Primary DI
- 00884838093225
- Version / Model
- Avalon Toco+ Transducer
- Catalog Number
- 867249
- 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
- 87fa9acd-852b-4b24-8097-903bee743558
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 |
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | 870.1025 | 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 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Cardiovascular | 870.2780 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | Cardiovascular | 870.2850 | 2 |
| HGL | Transducer, Ultrasonic, Obstetric | Obstetrics/Gynecology | 884.2960 | 2 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | Obstetrics/Gynecology | 884.2720 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | 870.2300 | 2 |
| HFN | Transducer, Pressure, Intrauterine | Obstetrics/Gynecology | 884.2700 | 2 |
| DSF | Recorder, Paper Chart | Cardiovascular | 870.2810 | 1 |
| DXQ | Blood Pressure Cuff | Cardiovascular | 870.1120 | 2 |
| DSJ | Alarm, Blood-Pressure | Cardiovascular | 870.1100 | 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 |
| MSX | System, Network And Communication, Physiological Monitors | Cardiovascular | 870.2300 | 2 |
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 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 | 00884838093225 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 16 – 107.5 KiloPascal