FDA UDI
In Commercial Distribution
🇺🇸 United States
Avalon Toco MP Transducer
DI: 00884838093218
·
Model: Avalon Toco MP Transducer
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
20
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Avalon Toco MP Transducer
- Primary DI
- 00884838093218
- Version / Model
- Avalon Toco MP Transducer
- Catalog Number
- 867248
- 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
- c9edb940-133b-49d3-ac0a-000ece2c8c44
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)
- Yes
- 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 |
|---|---|---|---|---|
| HFM | Monitor, uterine contraction, external (for use in clinic) | Obstetrics/Gynecology | 884.2720 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Cardiovascular | 870.2910 | 2 |
| DXQ | Blood Pressure Cuff | Cardiovascular | 870.1120 | 2 |
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
| DSK | Computer, Blood-Pressure | Cardiovascular | 870.1110 | 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 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | Cardiovascular | 870.1435 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | 870.2900 | 2 |
| MSX | System, Network And Communication, Physiological Monitors | Cardiovascular | 870.2300 | 2 |
| DSF | Recorder, Paper Chart | Cardiovascular | 870.2810 | 1 |
| HFN | Transducer, Pressure, Intrauterine | Obstetrics/Gynecology | 884.2700 | 2 |
| DSI | Detector And Alarm, Arrhythmia | Cardiovascular | 870.1025 | 2 |
| DSJ | Alarm, Blood-Pressure | Cardiovascular | 870.1100 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
| HGL | Transducer, Ultrasonic, Obstetric | Obstetrics/Gynecology | 884.2960 | 2 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Cardiovascular | 870.2780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37258 | Tocodynamometer probe | A pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838093218 | 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