BD BACTEC™ Blood Culture Procedural Tray - BACTEC Blood Culture Procedural Tray - BECTON, DICKINSON AND COMPANY

Duns Number:122561087

Device Description: BACTEC Blood Culture Procedural Tray

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More Product Details

Catalog Number

442805

Brand Name

BD BACTEC™ Blood Culture Procedural Tray

Version/Model Number

442805

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MDB

Product Code Name

SYSTEM, BLOOD CULTURING

Device Record Status

Public Device Record Key

79c39f4f-10cc-4015-bcec-31804206f081

Public Version Date

June 25, 2018

Public Version Number

1

DI Record Publish Date

May 25, 2018

Additional Identifiers

Package DI Number

30382904428052

Quantity per Package

20

Contains DI Package

00382904428051

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