Duns Number:078972580
Device Description: LifePort® Kidney Transporter Disposable Universal SealRing® Cannula (5mm)
Catalog Number
-
Brand Name
LifePort® Kidney Transporter
Version/Model Number
UCAN0005
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)
Yes
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
K021362,K021362
Product Code
KDL
Product Code Name
Set, Perfusion, Kidney, Disposable
Public Device Record Key
16ec2f63-1ed7-45f3-a530-64e56ee7388a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 16, 2017
Package DI Number
20815045020241
Quantity per Package
5
Contains DI Package
00815045020223
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 18 |