Duns Number:090266979
Device Description: Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preserva Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL
Catalog Number
-
Brand Name
Waters IGL Pulsatile Perfusion Solution
Version/Model Number
PPS/1000/US
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080432,K080432
Product Code
KDN
Product Code Name
System, Perfusion, Kidney
Public Device Record Key
e01a802a-6a4c-4d5a-84f5-06cbfd1c4ad0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 22, 2016
Package DI Number
10810805000177
Quantity per Package
6
Contains DI Package
00810805000170
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |