TOF-MU TOF-MU

GUDID 03665023000030

Main unit ToFscan

IDMED

Neuromuscular transmission lead set

• Primary Device ID: 03665023000030
• NIH Device Record Key: 5a9bb2fa-891a-43e5-add3-2c8cbd0f97e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOF-MU
• Version Model Number: TOF-MU
• Catalog Number: TOF-MU
• 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: 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	03665023000030 [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

On-Brand Devices [TOF-MU]

• 03665023000344: Main unit ToFscan
• 03665023000030: Main unit ToFscan