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

Duns Number:122561087

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

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

442020

Brand Name

BD BACTEC™ Peds Plus™/ F Culture Vials

Version/Model Number

442020

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

K151866,K151866

Product Code Details

Product Code

MDB

Product Code Name

SYSTEM, BLOOD CULTURING

Device Record Status

Public Device Record Key

45b3638c-9b80-461e-95e2-aa2cd93e953f

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 25, 2018

Additional Identifiers

Package DI Number

30382904420209

Quantity per Package

50

Contains DI Package

00382904420208

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