Aleve

Basic Information

• Brand Name: Aleve
• Primary DI: 00016500574057
• Version / Model: 1613538
• Company Name: BAYER HEALTHCARE LLC
• Labeler DUNS: 112117283
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-01
• Public Version: 4
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: 9ef83ab7-8a4d-4c50-80fc-7792855cb39c
• Distribution End Date: 2019-06-07

Device Description

Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 2 pairs of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35372	Analgesic transcutaneous electrical nerve stimulation system	An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10016500574054	GS1		6	Not in Commercial Distribution	2019-06-07
Primary	00016500574057	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius