BD Intraosseous Vascular Access System - BD Intraosseous Powered Driver - Bard Access Systems, Inc.

Duns Number:044611812

Device Description: BD Intraosseous Powered Driver

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More Product Details

Catalog Number

D001001

Brand Name

BD Intraosseous Vascular Access System

Version/Model Number

D001001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

07c71822-aede-4a34-a063-89f4b9c192b7

Public Version Date

January 22, 2020

Public Version Number

2

DI Record Publish Date

November 25, 2019

Additional Identifiers

Package DI Number

10801741163576

Quantity per Package

1

Contains DI Package

00801741163579

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"BARD ACCESS SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 3348
U Unclassified 8