Biowave Noninvasive Electrodes

Basic Information

• Brand Name: Biowave Noninvasive Electrodes
• Primary DI: 00859911006089
• Version / Model: MK78560 - BWEN01-B
• Company Name: BIOWAVE CORPORATION
• Labeler DUNS: 005759084
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 3
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 9df6c892-e148-4962-9d8a-0dc4418972a3

Device Description

Biowave Noninvasive Electrode - B-Set

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: 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: Yes
• 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
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	2
LIH	Interferential Current Therapy	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35995	Transcutaneous electrical stimulation electrode, single-use	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20859911006083	GS1	Case - Noninvasive B	250	In Commercial Distribution
Package	10859911006086	GS1	10-pack zip lock - B	10	In Commercial Distribution
Primary	00859911006089	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius