WiTOF

GUDID 03665023000610

WiTOF Demonstration kit (WiTOF-MU, power supply, clamp, hand and foot sensors (WiTOFS and WiTOF-FS), user manual, patient simulator)

IDMED

Neuromuscular transmission lead set

• Primary Device ID: 03665023000610
• NIH Device Record Key: 702024e0-d837-4c56-bf5a-e77b87ef7436
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WiTOF
• Version Model Number: WiTOF-DEMO
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665023000610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243339

FDA Product Code

• KOI: Stimulator, Nerve, Peripheral, Electric

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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [WiTOF]

• 03665023000610: WiTOF Demonstration kit (WiTOF-MU, power supply, clamp, hand and foot sensors (WiTOFS and WiTOF-
• 03665023000573: Foot sensor and electrodes connector
• 03665023000566: WiTOF complete kit (WiTOF-MU, power supply, clamp, hand sensor (WiTOF-S), user manual)
• 03665023000559: Hand sensor and electrodes connector
• 03665023000542: WiTOF main unit (branded Draeger)
• 03665023000535: Main unit WiTOF (branded IDMED)