EPSIMED

GUDID 04255629200904

EPSIMED NT- 100 Neuromuscular Transmission Monitor

EPSIMED LLC

Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system

• Primary Device ID: 04255629200904
• NIH Device Record Key: 82adefcb-3717-4b0f-b600-7e4c4acc8299
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPSIMED
• Version Model Number: NT-100
• Company DUNS: 079406295
• Company Name: EPSIMED LLC
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04255629200904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212434

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: 2023-11-02
• Device Publish Date: 2023-10-25

On-Brand Devices [EPSIMED]

• 06941900604292: EPSIMED MN-100 Patient Monitor SN: J4700SG00067
• 06941900604315: EPSIMED MN-150 PATIENT MONITOR
• 06975899060074: EPSIMED OL-100 Surgical Lights Series
• 04255629200904: EPSIMED NT- 100 Neuromuscular Transmission Monitor