Duns Number:590153276
Device Description: SU FACE MASK NON VENTED 10/BOX
Catalog Number
0T30
Brand Name
FISHER & PAYKEL HEALTHCARE
Version/Model Number
RT041M
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
K083122,K083122
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
8b5316f4-b678-4249-a515-d9d193a59212
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
September 25, 2015
Package DI Number
09420012421500
Quantity per Package
10
Contains DI Package
09420012429865
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |