Catalog Number

DT116C

Brand Name

SOFT-LINE®DUO-FLOW®

Version/Model Number

DT116C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 23, 2022

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

fba769f3-3b2d-46dd-b8a7-fffd8170ac08

Public Version Date

September 01, 2022

Public Version Number

3

DI Record Publish Date

July 11, 2019

Package DI Number

50884908143497

Quantity per Package

10

Contains DI Package

00884908143492

Package Discontinue Date

August 23, 2022

Package Status

Not in Commercial Distribution

Package Type

box