NeuroPlex E128 12889

GUDID 00814901021473

Non-sterile NeuroPlex E128: PN-12889 (Replacing PN-10906)

BLACKROCK MICROSYSTEMS, LLC

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• Primary Device ID: 00814901021473
• NIH Device Record Key: 095e1fad-8c5b-4ce7-bb4d-006c0ec6981c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPlex E128
• Version Model Number: 12889
• Catalog Number: 12889
• Company DUNS: 827132015
• Company Name: BLACKROCK MICROSYSTEMS, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814901021473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202174

FDA Product Code

• GWL: Amplifier, Physiological Signal

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: 2023-05-26
• Device Publish Date: 2023-05-18

Devices Manufactured by BLACKROCK MICROSYSTEMS, LLC

• 00814901021527 - Digital NeuroPort Biopotential Signal Processing System: 2023-12-12 Gemini Hub Neural Signal Processor
• 00814901021534 - Digital NeuroPort Biopotential Signal Processing System: 2023-12-12 Gemini Neural Signal Processor
• 00814901021497 - Blackrock NeuroPort Biopotential Signal Processing System: 2023-07-24 NeuroPort Central Suite
• 00814901021473 - NeuroPlex E128: 2023-05-26Non-sterile NeuroPlex E128: PN-12889 (Replacing PN-10906)
• 00814901021473 - NeuroPlex E128: 2023-05-26 Non-sterile NeuroPlex E128: PN-12889 (Replacing PN-10906)
• 00814901021480 - NeuroPlex E128 Sterile: 2023-05-26 Sterile NeuroPlex E128: PN-12890 (Replacing PN-10907)
• 00814901021466 - Blackrock NeuroPort Biopotential Signal Processing System: 2023-05-25 NeuroPort Central Suite
• 00814901021459 - Blackrock NeuroPort Biopotential Signal Processing System: 2022-10-05 NeuroPort Central Suite
• 00814901021435 - Digital NeuroPort Biopotential Signal Processing System: 2022-09-28 Gemini Neural Signal Processor