Duns Number:590153276
Device Description: FlexiFit 406 Petite Nasal Mask for CPAP or Bi-level ventilation
Catalog Number
HC406A
Brand Name
Fisher and Paykel Healthcare
Version/Model Number
HC406A
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
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
a3b4ff34-317f-47d7-a91a-dce1860434a5
Public Version Date
August 10, 2022
Public Version Number
1
DI Record Publish Date
August 02, 2022
Package DI Number
09420012429179
Quantity per Package
10
Contains DI Package
09420012418265
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 |