Catalog Number

221240

Brand Name

BD BBL™ GC II Agar with IsoVitaleX™ Enrichment

Version/Model Number

221240

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

K945569,K945569,K945569

Product Code

JSO

Product Code Name

CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR

Public Device Record Key

2babbdd2-d69c-4dac-ba47-e1d0e0ebccf8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 21, 2016

Package DI Number

30382902212400

Quantity per Package

2

Contains DI Package

10382902212406

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack