Inspiration 7i Ventilator System F7300000-7i-L-US

GUDID B079EVM11000101US0

Inspiration Ventilator System, model 7i with 17" Display Panel

Event Medical, Ltd.

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

• Primary Device ID: B079EVM11000101US0
• NIH Device Record Key: 5c753e04-3c5f-468d-923f-5bf7e8bd301e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inspiration 7i Ventilator System
• Version Model Number: Inspiration Ventilator System
• Catalog Number: F7300000-7i-L-US
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-900-1917
• Email: r.waters@event-medical.com
• Phone: 949-900-1917
• Email: r.waters@event-medical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B079EVM11000101US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130178

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-19

On-Brand Devices [Inspiration 7i Ventilator System]

• B079EVM11000103US0: Inspiration Ventilator System, model 7i Flagship with 17" Display Panel
• B079EVM11000102US0: Inspiration Ventilator System, model 7i with 12" Display Panel
• B079EVM11000101US0: Inspiration Ventilator System, model 7i with 17" Display Panel