Bio-logic

Basic Information

• Brand Name: Bio-logic
• Primary DI: 00382830000987
• Version / Model: Halo Ear Muffin with Tab Electrode
• Catalog Number: 206202
• Company Name: NATUS MEDICAL INCORPORATED
• Labeler DUNS: 962519208
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-31
• Public Version: 4
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: d29cd0c8-ef95-4cd1-ad29-f3359e6abbdb

Device Description

Halo Ear Muffins with Tab Electrodes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWO	Audiometer	Ear, Nose, Throat	874.1050	2
GWJ	Stimulator, Auditory, Evoked Response	Neurology	882.1900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11440	Analytical scalp electrode, single-use	A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active
41232	Acoustic earmuffs	A device that is worn over the ears to protect the user's hearing from excessive levels of noise, typically when using noisy machinery. It consists of a two hard plastic cups (one to fit over each ear) that are lined with sound attenuating material with soft ear cushions/pads on the outer rim. The cups are held together with a headband that is sprung to gently hold the cups against the side of the head. Included are types that also provide warmth and which are used for cold outdoor weather conditions. Also known as ear defenders. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382830000987	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 60 – 80 Degrees Fahrenheit