Well at Walgreens

Basic Information

• Brand Name: Well at Walgreens
• Primary DI: 00311917176383
• Version / Model: FDES105B
• Company Name: WALGREEN CO.
• Labeler DUNS: 008965063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-08-16
• Public Version: 4
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: 34a5ac25-8cd4-4b5c-bcbf-82a67f84e73a

Device Description

1 Tens control unit with 1 pc of 53 mm x 73 mm pad, 1pc of 190 mm X 95 mm pad & battery .

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: Yes
• 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: 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
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	10311917176380	GS1	Case	12	Not in Commercial Distribution	2016-10-19
Primary	00311917176383	GS1
Unit of Use	20311917176387	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130723	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit