ViVi Helmet 80100

GUDID 09009607801004

THI Total Healthcare Innovation GmbH

Surgical helmet system

• Primary Device ID: 09009607801004
• NIH Device Record Key: 4541e03e-0218-4b06-85ac-9190abdc93bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViVi Helmet
• Version Model Number: 80100
• Catalog Number: 80100
• Company DUNS: 300188850
• Company Name: THI Total Healthcare Innovation GmbH
• 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: 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

Customer Support Contacts

• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com
• Phone: 1-858-822-9433
• Email: vincebates@ivysurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09009607801004 [Primary]

FDA Product Code

• FXY: Hood, Surgical

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: 2023-11-20
• Device Publish Date: 2023-11-10

Devices Manufactured by THI Total Healthcare Innovation GmbH

• 19009607822204 - ViVi TOGA Premium Size XL-XXL: 2025-06-23
• 19009607822211 - ViVi TOGA Premium Size M-L: 2025-06-23
• 19009607822228 - ViVi TOGA Premium Size XXS-S: 2025-06-23
• 19009607832203 - ViVi TOGA Premium Size XL-XXL: 2025-06-23
• 19009607832210 - ViVi TOGA Premium Size M-L: 2025-06-23
• 19009607832227 - ViVi TOGA Premium Size XXS-S: 2025-06-23
• 19009607815008 - ViVi PEEL-OFF HOOD: 2025-06-18
• 09009607801004 - ViVi Helmet: 2023-11-20
• 09009607801004 - ViVi Helmet: 2023-11-20