Catalog Number

-

Brand Name

FK30100G

Version/Model Number

FK30100G

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

a7e2356b-e626-4195-bd32-9579ff6cf54a

Public Version Date

March 29, 2019

Public Version Number

1

DI Record Publish Date

March 21, 2019

Package DI Number

10850005864087

Quantity per Package

48

Contains DI Package

00850005864080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-