Baldoni Neuromodulation

GUDID 10860002528318

Heating TENS Device Set

BALDONI NEUROMODULATION LLC

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 10860002528318
• NIH Device Record Key: 128535a3-e972-4623-a265-3f1b6330ac0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baldoni Neuromodulation
• Version Model Number: BN19HTS
• Company DUNS: 117020160
• Company Name: BALDONI NEUROMODULATION 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002528311 [Primary]
GS1	10860002528318 [Package]; Contains: 00860002528311; Package: [20 Units]; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-21
• Device Publish Date: 2020-01-13