MREplus

GUDID 00850011790007

RESOUNDANT, INC.

MRI system application software

• Primary Device ID: 00850011790007
• NIH Device Record Key: 122ad806-3ec2-4375-9fc2-aa8f703d7984
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MREplus
• Version Model Number: MREplus 3.0.0DKR
• Company DUNS: 036969003
• Company Name: RESOUNDANT, INC.
• 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: true
• Serial Number: false
• 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	00850011790007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183193

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: 2021-04-09
• Device Publish Date: 2021-04-01

On-Brand Devices [MREplus]

• 00850011790014: MREplus 3.0.0WIN
• 00850011790007: MREplus 3.0.0DKR