Duns Number:044611812
Device Description: Power-Trialysis Short-Term Straight Dialysis Catheter Full Procedure Tray
Catalog Number
5605200G
Brand Name
Power-Trialysis
Version/Model Number
5605200G
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NIE
Product Code Name
CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
Public Device Record Key
a08078da-7fab-4f65-8edd-a2420bb783d6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 02, 2015
Package DI Number
10801741100151
Quantity per Package
5
Contains DI Package
00801741100154
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |