Catalog Number

-

Brand Name

SAM IO Intraosseous Access System

Version/Model Number

IO705-5P-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

K191488,K191488

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

cb941db2-08e3-4ba5-86d8-b8b283ac377b

Public Version Date

December 14, 2020

Public Version Number

2

DI Record Publish Date

February 26, 2020

Package DI Number

20822045000272

Quantity per Package

6

Contains DI Package

10822045000275

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case