BD BACTEC™ Plus Anaerobic/F Culture Vials - BD BACTEC™ Plus Anaerobic/F Culture Vials - BECTON, DICKINSON AND COMPANY

Duns Number:122561087

Device Description: BD BACTEC™ Plus Anaerobic/F Culture Vials

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More Product Details

Catalog Number

442193

Brand Name

BD BACTEC™ Plus Anaerobic/F Culture Vials

Version/Model Number

442193

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)

Yes

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

K921133,K921133

Product Code Details

Product Code

MDB

Product Code Name

SYSTEM, BLOOD CULTURING

Device Record Status

Public Device Record Key

1bfcc54c-9ae5-4820-b94f-5468e768f023

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 25, 2018

Additional Identifiers

Package DI Number

30382904421930

Quantity per Package

50

Contains DI Package

00382904421939

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack

"BECTON, DICKINSON AND COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 611
2 A medical device with a moderate to high risk that requires special controls. 614
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4