Duns Number:590153276
Device Description: F&P Brevida Nasal Pillows Mask - XS-S/M-L
Catalog Number
BRE1SMA
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
BRE1SMA
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
K161412,K161412
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
b755ea66-4271-4e1e-b728-3088c5b61d70
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
09420012436405
Quantity per Package
10
Contains DI Package
09420012436399
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 159 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 349 |