Catalog Number

JT031301501

Brand Name

13F X 15CM JET FLOW ST CATHETER

Version/Model Number

JT031301501

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 26, 2019

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

1a90beb3-a6d0-4bc9-b750-5e0265a17539

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

July 20, 2015

Package DI Number

50810988020267

Quantity per Package

5

Contains DI Package

00810988020262

Package Discontinue Date

August 26, 2019

Package Status

Not in Commercial Distribution

Package Type

-