EVOLUTION

GUDID B079EVL100500T1

Event Medical, Ltd.

General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator General-purpose intensive-care ventilator

• Primary Device ID: B079EVL100500T1
• NIH Device Record Key: 2b0ab34a-7ae5-407f-995f-6d2e89131063
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOLUTION
• Version Model Number: T
• Company DUNS: 791890861
• Company Name: Event Medical, Ltd.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com
• Phone: 9499001917
• Email: Customer.Service@event-medical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B079EVL100500T1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113743

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 2020-08-28
• Device Publish Date: 2020-08-20

Devices Manufactured by Event Medical, Ltd.

• 00860008873606 - eVolution 3e Ventilator: 2022-08-18 eVolution 3e Ventilator System
• 00860008873637 - INSPIRATION 7i Ventilator: 2022-08-08 INSPIRATION 7i Ventilator System, 17" screen
• B079EVL100500T1 - EVOLUTION: 2020-08-28
• B079EVL100500T1 - EVOLUTION: 2020-08-28
• B079EVM11000101US0 - Inspiration 7i Ventilator System: 2018-07-06 Inspiration Ventilator System, model 7i with 17" Display Panel
• B079EVM11000102US0 - Inspiration 7i Ventilator System: 2018-07-06 Inspiration Ventilator System, model 7i with 12" Display Panel
• B079EVM11000103US0 - Inspiration 7i Ventilator System: 2018-07-06 Inspiration Ventilator System, model 7i Flagship with 17" Display Panel