AccessGUDID - DEVICE: Aleve (00016500574057)

GUDID

Device Identifier (DI) Information

Brand Name: Aleve
Version or Model: 1613538
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BAYER HEALTHCARE LLC

Primary DI Number: 00016500574057
Issuing Agency: GS1
Commercial Distribution End Date: June 07, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 112117283 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ef83ab7-8a4d-4c50-80fc-7792855cb39c
Public Version Date: October 23, 2019
Public Version Number: 4
DI Record Publish Date: September 01, 2017