Beurer

Basic Information

• Brand Name: Beurer
• Primary DI: 00853879007300
• Version / Model: EM44 Replacement Electrodes Set
• Catalog Number: Art.- No. 642.72
• Company Name: BEURER NORTH AMERICA, L.P.
• Labeler DUNS: 078497467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2017-09-11
• Public Version: 4
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: b75fd186-b752-4df5-8282-5409d6426e77

Device Description

Replacement Electrodes Set for use with EM44 Beurer TENS Device (Art.- No. 642.71)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
GXY	Electrode, Cutaneous	Neurology	882.1320	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	20853879007304	GS1	Case Pack	30	In Commercial Distribution
Package	10853879007307	GS1	Inner Pack	5	In Commercial Distribution
Primary	00853879007300	GS1
Unit of Use	30853879007301	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	45	Millimeter
Width	45	Millimeter