MORPHEUS NM-0354

GUDID 00850154007079

Micromed MORPHEUS Amplifer for HOME LTM.

BLACKROCK NEUROMED, LLC

Electroencephalography telemetric monitoring system

• Primary Device ID: 00850154007079
• NIH Device Record Key: f439412e-a770-490a-a100-b156d9ef1940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MORPHEUS
• Version Model Number: NM-0354
• Catalog Number: NM-0354
• Company DUNS: 069799474
• Company Name: BLACKROCK NEUROMED, 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: false
• 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

Customer Support Contacts

• Phone: 801-994-5662
• Email: support@blackrockneuromed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850154007079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071782

FDA Product Code

• GWL: Amplifier, Physiological Signal

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: 2016-12-07

Devices Manufactured by BLACKROCK NEUROMED, LLC

• 00850154007086 - CERVELLO SOFTWARE: 2019-07-12 Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases.
• 00850154007079 - MORPHEUS: 2018-07-06Micromed MORPHEUS Amplifer for HOME LTM.
• 00850154007079 - MORPHEUS: 2018-07-06 Micromed MORPHEUS Amplifer for HOME LTM.
• 00850154007000 - CERVELLO 32: 2018-03-29 Cervello 32 LTM / Ambulatory Headbox, needs Jack Box - Bluetooth Model
• 00850154007017 - CERVELLO 64: 2018-03-29 Cervello 64 LTM / Ambulatory Headbox, needs Jack Box - Bluetooth Model
• 00850154007024 - CERVELLO 32 W: 2018-03-29 Cervello 32 LTM / Ambulatory Headbox, needs Jack Box - WiFi Model
• 00850154007031 - CERVELLO 64 W: 2018-03-29 Cervello 64 LTM / Ambulatory Headbox, needs Jack Box - WiFi Model
• 00850154007048 - JB CERVELLO 32: 2018-03-29 JackBox with 32 Common Reference Inputs, 21 arranged as Head Shape, 8 to be switched to Bipolar, to be used with CERVELLO 32 Ser
• 00850154007055 - JB CERVELLO 64: 2018-03-29 JackBox with 64 Common Reference Inputs, with 6 of them to be switched to Bipolar, to be used with CERVELLO 64 Series Headboxes