Duns Number:262411625
Device Description: The Breeze Facial Comfort Mask is designed for non invasive ventilation via the use of a b The Breeze Facial Comfort Mask is designed for non invasive ventilation via the use of a barometric device delivering Continuous Positive Airway Pressure (CPAP) or bi-level pressure (BiPAP).
Catalog Number
M-268020-21
Brand Name
Breeze
Version/Model Number
Breeze Facial Comfort S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
4f487eb1-1f49-44ec-a5ce-f99a7d78dbe7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |