Catalog Number

FCT50-24h

Brand Name

Flow Control Tubing

Version/Model Number

FCT 50ml/24hours (with syringe)

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

e1811898-4da8-4e51-b6b1-d9366b14cd4d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 18, 2017

Package DI Number

09350902001928

Quantity per Package

180

Contains DI Package

09350902001904

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping carton