Avalon CL Base Station

Basic Information

• Brand Name: Avalon CL Base Station
• Primary DI: 00884838034228
• Version / Model: Avalon CL Basestation
• Catalog Number: 866074
• 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: 2016-10-19
• Public Version: 8
• Public Version Date: 2023-05-05
• Public Version Status: Update
• Public Device Record Key: 94225874-c0e7-41ba-8c33-38eb57dae289

Device Description

Avalon CL Basestation. Basestation for Avalon cableless transducers with three slots for fetal transducers and one slot for maternal parameters or range extenstion module.

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: No
• 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
DRG	TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY	Cardiovascular	870.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66544	Foetal/maternal prenatal monitoring system transceiver	An electrically-powered component of a foetal/maternal prenatal monitoring system intended to be connected to the system transducer (tocodynamometer) to receive measurements (e.g., typically uterine contractions and foetal heart rate) acquired from the transducer and transmit them to the system monitor for further processing and/or display (transducer and monitor not included). The device might in addition be used to supply electrical energy to the transducer (charging). It typically has the form of a stationary one-piece or portable two-component unit (i.e., separate transmitter and receiver). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838034228	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity