spECTrum

GUDID 00861539000134

100 Joule ECT Device with 1 Parameter Setting Control

MECTA CORPORATION

Electroconvulsive therapy system

• Primary Device ID: 00861539000134
• NIH Device Record Key: 1b9eda53-23d0-47b0-a312-75e89389e642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: spECTrum
• Version Model Number: 4000DM
• Company DUNS: 037079324
• Company Name: MECTA CORPORATION
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (503) 612-6780
• Email: info@mectacorp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861539000134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K965070

FDA Product Code

• GXC: Device, Electroconvulsive Therapy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [spECTrum]

• 00861539000134: 100 Joule ECT Device with 1 Parameter Setting Control
• 00861539000127: 100 Joule ECT Device with 4 Parameter Setting Controls
• 00861539000110: 100 Joule ECT Device with 1 Parameter Setting Control and Patient Monitoring
• 00861539000103: 100 Joule ECT Device with 4 Parameter Setting Controls and Patient Monitoring