Duns Number:963236661
Device Description: Perotineal Dialysis Transfer Catheter
Catalog Number
-
Brand Name
Firefly Transfer Catheter
Version/Model Number
40398
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 01, 2016
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
-
Product Code
KDJ
Product Code Name
Set, Administration, For Peritoneal Dialysis, Disposable
Public Device Record Key
20d837bf-3dcc-4ded-8d8b-6b9829145960
Public Version Date
July 10, 2020
Public Version Number
3
DI Record Publish Date
November 21, 2016
Package DI Number
00865349000322
Quantity per Package
8
Contains DI Package
00865349000315
Package Discontinue Date
December 01, 2016
Package Status
Not in Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |