NC-stat DPNCheck DB-025, DB-050

GUDID 20851221006081

NC-stat DPNCheck Biosensor DB-025 = QTY 25 OF NC-DP2 DB-050 = QTY 50 OF NC-DP2

NEUROMETRIX, INC.

Electrode conductive medium

• Primary Device ID: 20851221006081
• NIH Device Record Key: 0f877755-673a-4a86-8543-ad57af60a511
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC-stat DPNCheck
• Version Model Number: NC-DP2
• Catalog Number: DB-025, DB-050
• 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: true
• Lot Batch: true
• Serial Number: false
• 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 -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006087 [Primary]
GS1	10851221006084 [Package]; Contains: 00851221006087; Package: Case [25 Units]; In Commercial Distribution
GS1	20851221006081 [Package]; Contains: 00851221006087; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041320

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: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2016-12-01

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