Passive Driver

GUDID 00850011790106

RESOUNDANT, INC.

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• Primary Device ID: 00850011790106
• NIH Device Record Key: e2bccce7-1771-44f6-9349-f77692607512
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Passive Driver
• Version Model Number: REPD2000
• Company DUNS: 036969003
• Company Name: RESOUNDANT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00850011790106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201389

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2023-03-01
• Device Publish Date: 2023-02-21

Devices Manufactured by RESOUNDANT, INC.

• 00850011790045 - Flex Passive Driver Kit- Large: 2023-04-10
• 00850011790052 - Flex Passive Driver Kit- Small: 2023-04-10
• 00850011790106 - Passive Driver: 2023-03-01
• 00850011790106 - Passive Driver: 2023-03-01
• 00850011790199 - Hepatogram Plus: 2022-04-21
• 00850011790007 - MREplus: 2021-04-09
• 00850011790014 - MREplus: 2021-04-09