ViVi Helmet HPL 80130

GUDID 09009607801301

THI Total Healthcare Innovation GmbH

Surgical helmet system

• Primary Device ID: 09009607801301
• NIH Device Record Key: 73e25561-7a20-4180-9fa7-160da0c2abbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViVi Helmet HPL
• Version Model Number: 80130
• Catalog Number: 80130
• 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	09009607801301 [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

• 09009607801004 - ViVi Helmet: 2023-11-20
• 09009607801301 - ViVi Helmet HPL: 2023-11-20
• 09009607801301 - ViVi Helmet HPL: 2023-11-20
• 09009607812000 - ViVi Hood: 2023-11-20