Duns Number:590153276
Device Description: WATER FEED SET EXTENSION 10CTN
Catalog Number
-
Brand Name
FISHER & PAYKEL HEALTHCARE
Version/Model Number
900MR191X
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
K953949,K953949
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
19aba5bd-224a-4b68-b7df-92e0de1904a7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 25, 2015
Package DI Number
09420012401472
Quantity per Package
10
Contains DI Package
09420012429797
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 |