Catalog Number

FG5006

Brand Name

LifeFlow Replacement Blood Tubing Sets

Version/Model Number

FG5006

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"

Yes

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

K191362

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

890e2ba6-f1c1-4e7d-bae4-fdb733fa2300

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

June 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-