Duns Number:590153276
Device Description: Non-vented Hospital Full Face Mask Standard Elbow Version - Large
Catalog Number
RT046L
Brand Name
Fisher & Paykel Healthcare
Version/Model Number
RT046L
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"
Yes
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
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
3b18a3a0-0219-4218-a771-94b39c1f9712
Public Version Date
October 14, 2019
Public Version Number
3
DI Record Publish Date
May 10, 2018
Package DI Number
09420012436221
Quantity per Package
10
Contains DI Package
09420012436214
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 |