AccessGUDID - DEVICE: Avalon CL Toco+ MP Transducer (00884838034235)

GUDID

Device Identifier (DI) Information

Brand Name: Avalon CL Toco+ MP Transducer
Version or Model: Avalon Cableless Toco+ MP Transducer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 866075
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838034235
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: Avalon Cableless Toco+ MP Transducer for use with Avalon CL Basestation 866074. Toco Transducer with Avalon Smart Pulse measurement and connector for maternal ECG, fetal ECG or IUP measurement.

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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFM	MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)

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 Temperature: between -4 and 140 Degrees Fahrenheit
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: ab313c63-54a9-4442-9402-86500b28f350
Public Version Date: May 05, 2023
Public Version Number: 8
DI Record Publish Date: October 19, 2016