Avalon CL Fetal & Maternal Pod

Basic Information

• Brand Name: Avalon CL Fetal & Maternal Pod
• Primary DI: 00884838068179
• Version / Model: Avalon CL Fetal & Maternal Pod
• Catalog Number: 866488
• 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: 2020-05-22
• Public Version: 5
• Public Version Date: 2023-07-13
• Public Version Status: Update
• Public Device Record Key: 7fbb5a25-9839-47f2-ac7d-1ed35a354583

Device Description

The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used together with the Avalon CL Basestation 866074.

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
HFM	Monitor, uterine contraction, external (for use in clinic)	Obstetrics/Gynecology	884.2720	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	00884838068179	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