Aleve

GUDID 00325866564948

2 pairs of Aleve Direct Therapy TENs Device Refill Gel Pads packaged in one re-sealable pouch.

BAYER HEALTHCARE LLC

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00325866564948
• NIH Device Record Key: 98aaee1b-904b-4407-9b03-0c3b4a1368d7
• Commercial Distribution Discontinuation: 2019-02-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aleve
• Version Model Number: 1613579
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00325866564948 [Primary]
GS1	10325866564945 [Package]; Package: [6 Units]; Not in Commercial Distribution
GS1	10325866572445 [Package]; Package: [6 Units]; 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: 2016-09-01

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