Catalog Number

-

Brand Name

SAM IO Intraosseous Access System

Version/Model Number

IO740-5P-EN

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

KMK

Product Code Name

Device, Intravascular Catheter Securement

Public Device Record Key

e346251f-c052-4dcc-9eaa-fb05b2004629

Public Version Date

June 05, 2020

Public Version Number

1

DI Record Publish Date

May 28, 2020

Package DI Number

30822045000309

Quantity per Package

6

Contains DI Package

10822045000305

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case