Catalog Number

DT116IJS-2

Brand Name

SOFT-LINE®DUO-FLOW®IJ

Version/Model Number

DT116IJS-2

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

472e233e-c21b-471f-a130-b7b2de00ffd4

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 17, 2019

Package DI Number

50884908146269

Quantity per Package

5

Contains DI Package

00884908146264

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box