Catalog Number

5432240

Brand Name

Niagara Slim-Cath catheter

Version/Model Number

5432240

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"

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

-

Product Code

MPB

Product Code Name

CATHETER, HEMODIALYSIS, NON-IMPLANTED

Public Device Record Key

49cf76e6-58f2-45b0-b723-d85989efb349

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

December 04, 2015

Package DI Number

20801741038482

Quantity per Package

20

Contains DI Package

10801741038485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX