Airsonett AIR-4
Basic Information
- Brand Name
- Airsonett AIR-4
- Primary DI
- 07350128750015
- Version / Model
- 4
- 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
- 6155874c-a971-49d0-a89d-163504a99814
Device Description
Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 | 07350128750015 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130702 | 000 |