Pillow Passive Driver Kit

GUDID 00850011790229

RESOUNDANT, INC.

Magnetic resonance elastography acoustic driver

• Primary Device ID: 00850011790229
• NIH Device Record Key: 66de6c1c-efbd-4147-b1a5-f6448bc81a10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pillow Passive Driver Kit
• Version Model Number: REFDAUX
• 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: false
• 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	00850011790229 [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: 2024-10-11
• Device Publish Date: 2024-10-03

Devices Manufactured by RESOUNDANT, INC.

• 00850011790229 - Pillow Passive Driver Kit: 2024-10-11
• 00850011790229 - Pillow Passive Driver Kit: 2024-10-11
• 00850011790045 - Flex Passive Driver Kit- Large: 2023-04-10
• 00850011790052 - Flex Passive Driver Kit- Small: 2023-04-10
• 00850011790106 - Passive Driver: 2023-03-01
• 00850011790199 - Hepatogram Plus: 2022-04-21
• 00850011790007 - MREplus: 2021-04-09
• 00850011790014 - MREplus: 2021-04-09