Catalog Number

400110

Brand Name

SecurAcath

Version/Model Number

5F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

KMK

Product Code Name

Device, Intravascular Catheter Securement

Public Device Record Key

8aecbda2-b4b4-4258-a1f0-23bd4d14d889

Public Version Date

June 04, 2020

Public Version Number

6

DI Record Publish Date

September 15, 2016

Package DI Number

10865382000225

Quantity per Package

10

Contains DI Package

00865382000228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box