Catalog Number

AS0912151

Brand Name

DUO-FLOW®

Version/Model Number

AS0912151

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

84c38ebd-ba76-4315-b696-7cca9b915441

Public Version Date

February 22, 2021

Public Version Number

1

DI Record Publish Date

February 13, 2021

Package DI Number

50884908136925

Quantity per Package

10

Contains DI Package

00884908136920

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box