Neurophet AQUA

GUDID 08800130400167

NEUROPHET Inc.

MRI system application software

• Primary Device ID: 08800130400167
• NIH Device Record Key: 1c5db91d-8512-4203-9812-d2f00499ed5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neurophet AQUA
• Version Model Number: 3.0
• Company DUNS: 694626491
• Company Name: NEUROPHET Inc.
• 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: true
• 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	08800130400167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220437

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-06-29
• Device Publish Date: 2023-06-21

On-Brand Devices [Neurophet AQUA]

• 08800130400167: 3.0
• 08800130400242: 3.1