Catalog Number

FCT30-30m

Brand Name

Flow Control Tubing

Version/Model Number

FCT 30mL/30min

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

57bd7737-930d-443b-812b-1bf96134d349

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 16, 2017

Package DI Number

09350902000839

Quantity per Package

300

Contains DI Package

09350902000815

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping carton