Catalog Number

5653120

Brand Name

Power-Trialysis Alphacurve catheter

Version/Model Number

5653120

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

-

Product Code

NIE

Product Code Name

CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Public Device Record Key

10d3f309-363d-4b55-908f-911e501d5e53

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 06, 2015

Package DI Number

20801741066010

Quantity per Package

10

Contains DI Package

10801741066013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX