Catalog Number

-

Brand Name

Tubing set

Version/Model Number

6022EXC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 17, 2017

Issuing Agency

In HIBCC

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

K071588,K071588

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

d0101eed-63fd-4325-8e98-cb097f42f3d0

Public Version Date

April 23, 2019

Public Version Number

6

DI Record Publish Date

January 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-