TOF-CHAR_US TOF-CHAR_US

GUDID 03665023000122

AC Power / Charger (US electrical sockets)

IDMED

Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set Neuromuscular transmission lead set

• Primary Device ID: 03665023000122
• NIH Device Record Key: 94faf51a-5802-4eb6-af9c-a61c9799e2cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOF-CHAR_US
• Version Model Number: TOF-CHAR_US
• Catalog Number: TOF-CHAR_US
• Company DUNS: 260233256
• Company Name: IDMED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665023000122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172690

FDA Product Code

• KOI: Stimulator, Nerve, Peripheral, Electric

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: 2023-12-18
• Device Publish Date: 2018-07-13

Devices Manufactured by IDMED

• 03665023000030 - TOF-MU: 2023-12-18 Main unit ToFscan
• 03665023000122 - TOF-CHAR_US: 2023-12-18AC Power / Charger (US electrical sockets)
• 03665023000122 - TOF-CHAR_US: 2023-12-18 AC Power / Charger (US electrical sockets)
• 03665023000153 - TOF-STICKER1: 2023-12-18 Double-sided stickers for eyebrow sensor (96 units)
• 03665023000344 - TOF-MU: 2023-12-18 Main unit ToFscan
• 03665023000047 - TOF-S2: 2023-03-01 Hand sensor and electrodes connector
• 03665023000078 - TOF-ES: 2023-03-01 Eyebrow sensor and electrodes connector
• 03665023000368 - TOF-DEMO: 2022-06-21 Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp
• 03665023000375 - TOF-DEMO_F: 2022-06-21 Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp