Catalog Number

D015351MK

Brand Name

BD Intraosseous Vascular Access System

Version/Model Number

D015351MK

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"

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

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

322ac492-4467-42b5-b4cf-d53d73d34962

Public Version Date

March 25, 2021

Public Version Number

1

DI Record Publish Date

March 17, 2021

Package DI Number

20801741163641

Quantity per Package

2

Contains DI Package

10801741163644

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX