Airsonett AIR-4 A-1100

GUDID 07350128750022

Exchangeable filter to Airsonett AIR-4

Airsonett AB

Mobile laminar airflow unit Mobile laminar airflow unit Mobile laminar airflow unit Mobile laminar airflow unit Mobile laminar airflow unit

• Primary Device ID: 07350128750022
• NIH Device Record Key: db1c7ff7-8761-4c17-8685-904a52655c28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Airsonett AIR-4 A-1100
• Version Model Number: A-1100
• Company DUNS: 775813962
• Company Name: Airsonett AB
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350128750022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130702

FDA Product Code

• FRF: Cleaner, Air, Medical Recirculating

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: 2023-02-09
• Device Publish Date: 2023-02-01

Devices Manufactured by Airsonett AB

• 07350128750015 - Airsonett AIR-4: 2023-02-09 Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett an
• 07350128750022 - Airsonett AIR-4 A-1100: 2023-02-09Exchangeable filter to Airsonett AIR-4
• 07350128750022 - Airsonett AIR-4 A-1100: 2023-02-09 Exchangeable filter to Airsonett AIR-4