Catalog Number

FEXT

Brand Name

HIgH-Flo™, RMS Precision Flow Rate TubingTM

Version/Model Number

FEXT

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"

-

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

FRN

Product Code Name

Pump, infusion

Public Device Record Key

5fe31f3f-3f14-45be-aa0c-f6d34df62054

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 19, 2016

Package DI Number

10659443000695

Quantity per Package

20

Contains DI Package

00659443000698

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton