Aleve

GUDID 10016500574054

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.

BAYER HEALTHCARE LLC

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 10016500574054
• NIH Device Record Key: 9ef83ab7-8a4d-4c50-80fc-7792855cb39c
• Commercial Distribution Discontinuation: 2019-06-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aleve
• Version Model Number: 1613538
• Company DUNS: 112117283
• Company Name: BAYER HEALTHCARE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-395-0689
• Email: cc-consreldept@bayer.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016500574057 [Primary]
GS1	10016500574054 [Package]; Contains: 00016500574057; Package: [6 Units]; Discontinued: 2019-06-07; Not in Commercial Distribution

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-09-01

On-Brand Devices [Aleve]

• 10325866565041: Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same
• 00325866564948: 2 pairs of Aleve Direct Therapy TENs Device Refill Gel Pads packaged in one re-sealable pouch.
• 10016500574054: Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same