Airsonett AIR-4 A-1100

Basic Information

• Brand Name: Airsonett AIR-4 A-1100
• Primary DI: 07350128750022
• Version / Model: A-1100
• Company Name: Airsonett AB
• Labeler DUNS: 775813962
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-01
• Public Version: 1
• Public Version Date: 2023-02-09
• Public Version Status: New
• Public Device Record Key: db1c7ff7-8761-4c17-8685-904a52655c28

Device Description

Exchangeable filter to Airsonett AIR-4

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRF	Cleaner, Air, Medical Recirculating	General Hospital	880.5045	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35498	Mobile laminar airflow unit	A device designed to displace the entire air mass within an enclosure (e.g., a room), with uniform velocity and parallel direction, to remove contaminants; it is part of a mobile cabinet or mount. Air is typically drawn from the environment into the system by negative pressure created by a blower; air particles and liquid droplets are removed usually using high-efficiency particulate air (HEPA) filters. Filtered air is then circulated into the enclosure and exhausted or recirculated. The device is intended to provide temporary isolation of patients avoiding contamination and/or to perform procedures in a contaminated-free environment in emergency situations.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350128750022	GS1

Premarket Submissions

Submission Number	Supplement Number
K130702	000