MONSOON+ 7700.US

GUDID 07640140861616

High frequency ventilator

Acutronic Medical Systems AG

Stationary electric high-frequency ventilator

• Primary Device ID: 07640140861616
• NIH Device Record Key: 4df212cf-5145-437e-bd08-053cd2144afd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONSOON+
• Version Model Number: 7700.US
• Catalog Number: 7700.US
• Company DUNS: 481327922
• Company Name: Acutronic Medical Systems AG
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41447297080
• Email: regulatory@acutronic-medical.ch

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640140861616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012691

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: 4
• Public Version Date: 2019-11-06
• Device Publish Date: 2016-10-12