Duns Number:590153276
Device Description: F&P Evora Full Face PAP Therapy Mask - Fit Pack XS/S-M/L SLA
Catalog Number
EVF1XMLSLA
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
EVF1XMLSLA
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
K212371,K212371
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
98958fa7-b44e-4684-a0ad-c6869a237c9a
Public Version Date
April 05, 2022
Public Version Number
1
DI Record Publish Date
March 28, 2022
Package DI Number
09420012472533
Quantity per Package
10
Contains DI Package
09420012471796
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 |