DPNCheck

GUDID 00816022023695

DPNCheck 2.0 Biosensors, QTY 25 - Kit containing QTY 25 of NC-DP2 (00816022023688)

IMPULSE MEDICAL TECHNOLOGIES, INC.

Electrode conductive medium

• Primary Device ID: 00816022023695
• NIH Device Record Key: 86af4887-7396-4765-a978-3653c21de4cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DPNCheck
• Version Model Number: DB-025-Training
• Company DUNS: 080015502
• Company Name: IMPULSE MEDICAL TECHNOLOGIES, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816022023695 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-19
• Device Publish Date: 2026-01-09

On-Brand Devices [DPNCheck]

• 00816022023718: DPNCheck 2.0 Biosensor, QTY 50 - China, Kit containing QTY 50 of NC-DP2 (00816022023688) for the
• 00816022023701: DPNCheck 2.0 Biosensor, QTY 50 - Kit containing QTY 50 of NC-DP2 (00816022023688)
• 00816022023695: DPNCheck 2.0 Biosensors, QTY 25 - Kit containing QTY 25 of NC-DP2 (00816022023688)
• 00816022023688: DPNCheck 2.0 Biosensor
• 00816022023671: DPNCheck 2.0 Device - China (for sale in Chinese market)
• 00816022023664: DPNCheck 2.0 Device
• 00816022023657: DPNCheck Device