Catalog Number

-

Brand Name

Marksman

Version/Model Number

FA-55150-1030

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

K091559

Product Code

KRA

Product Code Name

Catheter, continuous flush

Public Device Record Key

54d03e6c-4ebb-421b-9cb4-9e37c7c12011

Public Version Date

June 27, 2019

Public Version Number

7

DI Record Publish Date

October 12, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-