LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295130379
• Version / Model: 5297478
• Catalog Number: 5297478
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-14
• Public Version: 5
• Public Version Date: 2023-03-08
• Public Version Status: Update
• Public Device Record Key: 8f89714c-e98b-40e6-94f0-c150e9a42b3a
• Distribution End Date: 2020-10-27

Device Description

LDR TENS Electro-Therapy Kit 1 ea

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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	30096295130370	GS1	BOX	4	Not in Commercial Distribution	2020-10-27
Primary	00096295130379	GS1
Package	50096295130374	GS1	CASE	12	Not in Commercial Distribution	2020-10-27

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 95 Percent (%) Relative Humidity