NC-stat DPNCheck

GUDID 00851221006261

NC-stat DPNCheck Device

NEUROMETRIX, INC.

Diagnostic peripheral nerve electrical stimulation system

• Primary Device ID: 00851221006261
• NIH Device Record Key: 28304cb9-7faa-4f2c-a2fd-851fc3502b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC-stat DPNCheck
• Version Model Number: NC-030
• Company DUNS: 957536014
• Company Name: NEUROMETRIX, INC.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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 -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006261 [Primary]

FDA Product Code

• JXE: Device, Nerve Conduction Velocity Measurement

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-08

On-Brand Devices [NC-stat DPNCheck]

• 00851221006261: NC-stat DPNCheck Device
• 20851221006081: NC-stat DPNCheck Biosensor DB-025 = QTY 25 OF NC-DP2 DB-050 = QTY 50 OF NC-DP2