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

Duns Number:044611812

Device Description: BD Intraosseous Manual Driver

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More Product Details

Catalog Number

D015551MK

Brand Name

BD Intraosseous Vascular Access System

Version/Model Number

D015551MK

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"

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 Details

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

2c6786f7-9c02-4a02-b96a-9ee3fb521bf5

Public Version Date

March 25, 2021

Public Version Number

1

DI Record Publish Date

March 17, 2021

Additional Identifiers

Package DI Number

20801741163665

Quantity per Package

2

Contains DI Package

10801741163668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX

"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