INSPIRATION 7i Ventilator F7300000-7i-F, F7300000-7i-L

GUDID 00860008873637

INSPIRATION 7i Ventilator System, 17" screen

Event Medical, Ltd.

Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator

• Primary Device ID: 00860008873637
• NIH Device Record Key: 321e5fee-5b1b-4d0f-bf69-1020327963cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSPIRATION 7i Ventilator
• Version Model Number: INSPIRATION 7i Ventilator 17" screen
• Catalog Number: F7300000-7i-F, F7300000-7i-L
• 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: 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: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com
• Phone: 949-900-1917
• Email: a.hedayati@event-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008873637 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-08
• Device Publish Date: 2022-07-29

Devices Manufactured by Event Medical, Ltd.

• 00860008873606 - eVolution 3e Ventilator: 2022-08-18 eVolution 3e Ventilator System
• 00860008873637 - INSPIRATION 7i Ventilator: 2022-08-08INSPIRATION 7i Ventilator System, 17" screen
• 00860008873637 - INSPIRATION 7i Ventilator: 2022-08-08 INSPIRATION 7i Ventilator System, 17" screen
• 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