Catalog Number

AS0212201

Brand Name

12F TRI-FLOW TRIPLE LUMEN CATHETER12F TRI-FLOW TRIPLE LUMEN CATHETER

Version/Model Number

AS0212201

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

NIE

Product Code Name

CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Public Device Record Key

8375a728-4a41-435d-a5e9-adae05417b84

Public Version Date

November 12, 2018

Public Version Number

1

DI Record Publish Date

October 10, 2018

Package DI Number

50884908131654

Quantity per Package

5

Contains DI Package

00884908131659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box