Catalog Number

-

Brand Name

B-Smart

Version/Model Number

BS015-30

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

K031128,K031128,K031128

Product Code

CAZ

Product Code Name

Anesthesia Conduction Kit

Public Device Record Key

a957963e-5fc8-449a-96ac-c5bfc471a933

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 04, 2016

Package DI Number

38053676290018

Quantity per Package

25

Contains DI Package

18053676290014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Base box