Bio-logic

Basic Information

• Brand Name: Bio-logic
• Primary DI: 00382830008365
• Version / Model: Disposable Snap Electrodes
• Catalog Number: 101600; 101603
• Company Name: NATUS MEDICAL INCORPORATED
• Labeler DUNS: 962519208
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-30
• Public Version: 4
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 46e9cc32-c0a5-4552-a52c-6037ca92a259

Device Description

Disposable Snap Electrodes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00382830001427	GS1	101603	300	Not in Commercial Distribution	2017-08-01
Primary	00382830008365	GS1
Package	00382830001410	GS1	101600	60	Not in Commercial Distribution	2017-08-01
Package	00382830054928	GS1	101603	100	In Commercial Distribution
Package	00382830054911	GS1	101600	20	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1.31	Inch
Width	0.88	Inch