Duns Number:333802754
Device Description: Short-term use to obtain vasular access in patients with acute or chronic renal failure. T Short-term use to obtain vasular access in patients with acute or chronic renal failure. The GamCath HighFlow Dolphin Catheter combines the GamCath HighFlow Catheter with an additional coating based on a block copolymer.
Catalog Number
114022
Brand Name
GamCath HighFlow Dolphin Catheter
Version/Model Number
GAMCATH MS-GDHC-1115 A
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
K100451,K100451
Product Code
MPB
Product Code Name
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Public Device Record Key
afe0600b-0d2a-4a87-8cb5-50441862c7cf
Public Version Date
October 11, 2022
Public Version Number
5
DI Record Publish Date
October 07, 2015
Package DI Number
37332414110667
Quantity per Package
5
Contains DI Package
07332414110666
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. | 10 |