Innovision N/A

GUDID 00628176432212

Innovere Medical Inc

Patient audiovisual communication/entertainment system

• Primary Device ID: 00628176432212
• NIH Device Record Key: 3df011ba-5a6c-4e19-87cf-80d620585e07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innovision
• Version Model Number: 00
• Catalog Number: N/A
• Company DUNS: 259725661
• Company Name: Innovere Medical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00628176432212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193218

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: 2021-03-02
• Device Publish Date: 2021-02-22

On-Brand Devices [Innovision]

• 00628176432229: 00
• 00628176432212: 00