SENSUS

GUDID 00851221006285

SENSUS System Kit, 1 Device (Includes 1 SE-S01 or QE-P01)

NEUROMETRIX, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00851221006285
• NIH Device Record Key: d8ac9e42-5426-4d66-881d-06ad9b4295f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENSUS
• Version Model Number: SE-SK2
• Company DUNS: 957536014
• Company Name: NEUROMETRIX, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 781-314-2781
• Email: rainer_maas@neurometrix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130919

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-09

On-Brand Devices [SENSUS]

• 00851221006339: SENSUS System, 4-lead configuration 2 SE-001, SE-C01, charger, cable
• 00851221006322: SENSUS System Kit, 2 Devices (Includes 2 SE-S01) 2 SE-001 and 2 SE-S01 or QE-P01
• 00851221006285: SENSUS System Kit, 1 Device (Includes 1 SE-S01 or QE-P01)
• 00851221006278: SENSUS System, 2-lead configuration 1 SE-001, SE-C01, charger, cable