Catalog Number

FG5001

Brand Name

LifeFlow Rapid Infusion System

Version/Model Number

FG5001

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

K153731

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

000d0199-0c53-49f3-8dfc-ec57963e3d29

Public Version Date

November 30, 2018

Public Version Number

1

DI Record Publish Date

October 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-