Catalog Number

-

Brand Name

BKS E-Vitalize

Version/Model Number

166-7713

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

K152169

Product Code

JWY

Product Code Name

Manual antimicrobial susceptibility test systems

Public Device Record Key

ed1e76bb-d64c-43d8-8a77-24ef17f53c1c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-