Catalog Number

FCT10-48h

Brand Name

Flow Control Tubing

Version/Model Number

FCT 10mL/48h

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K910007,K910007,K910007

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

4be9e919-eee2-431f-aec7-82b1b770a89a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

9350902000716

Quantity per Package

600

Contains DI Package

09350902000693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer carton