Duns Number:565404779
Device Description: Permthane X split Long term dual lumen catheter kit size 14 Fr tip to cuff length 31 Cm to Permthane X split Long term dual lumen catheter kit size 14 Fr tip to cuff length 31 Cm total length 36 Cm
Catalog Number
-
Brand Name
Amecath X split catheter
Version/Model Number
PXDLC-1431-K
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 22, 2019
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"
Yes
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
K131814
Product Code
MSD
Product Code Name
Catheter, Hemodialysis, Implanted
Public Device Record Key
cf303911-2c9e-45a5-be04-0674b5755648
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
August 22, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 109 |