AccessGUDID - DEVICE: Avalon Toco MP Transducer (00884838093218)

GUDID

Device Identifier (DI) Information

Brand Name: Avalon Toco MP Transducer
Version or Model: Avalon Toco MP Transducer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 867248
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838093218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFM	Monitor, uterine contraction, external (for use in clinic)
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency
DXQ	Blood Pressure Cuff
FLL	Thermometer, Electronic, Clinical
HGM	System, Monitoring, Perinatal
DQA	Oximeter
DSK	Computer, Blood-Pressure
DRQ	Amplifier And Signal Conditioner, Transducer Signal
DRS	Transducer, Blood-Pressure, Extravascular
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)
MSX	System, Network And Communication, Physiological Monitors
DSF	Recorder, Paper Chart
HFN	Transducer, Pressure, Intrauterine
DSI	Detector And Alarm, Arrhythmia
DSJ	Alarm, Blood-Pressure
DXN	System, Measurement, Blood-Pressure, Non-Invasive
HGL	Transducer, Ultrasonic, Obstetric
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: c9edb940-133b-49d3-ac0a-000ece2c8c44
Public Version Date: October 31, 2024
Public Version Number: 5
DI Record Publish Date: March 08, 2021