Catalog Number

232174

Brand Name

BD BBL™ Sensi-Disc™ Ertapenem - 10 µg

Version/Model Number

232174

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

-

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

K020842

Product Code

JTN

Product Code Name

SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL

Public Device Record Key

f10ccfe8-6fc6-490f-a23b-0a1f0fa6076b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-