Catalog Number

400180

Brand Name

SecurAcath

Version/Model Number

10F

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

af851bb6-c62b-4ee7-9c8b-39397aed8ad8

Public Version Date

June 11, 2020

Public Version Number

1

DI Record Publish Date

June 03, 2020

Package DI Number

10865382000294

Quantity per Package

10

Contains DI Package

00865382000297

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box