Duns Number:590153276
Device Description: F&P Evora Nasal Mask - Fit Pack S/M/L A For Positive Airway Pressure Therapy
Catalog Number
EVO1SMLA
Brand Name
FISHER & PAYKEL HEALTHCARE
Version/Model Number
EVO1SMLA
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
Yes
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
0d0ce609-ef45-42b7-a3ed-c4a12d77e29c
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
July 26, 2021
Package DI Number
09420012459930
Quantity per Package
10
Contains DI Package
09420012456250
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 |