Digital TENS one channel

GUDID 04716770925509

BESMED HEALTH BUSINESS CORP.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 04716770925509
• NIH Device Record Key: a4bd4ada-1e31-420d-9bd1-04dcbd26eebb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital TENS one channel
• Version Model Number: BE-92550
• Company DUNS: 658023775
• Company Name: BESMED HEALTH BUSINESS CORP.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04716770925509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031374

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2016-09-06

On-Brand Devices [Digital TENS one channel]

• 04716770925509: BE-92550
• 04716770005607: BE-560