Catalog Number

-

Brand Name

Bivona

Version/Model Number

ZU18JS80ZSZ197N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K923878

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

694102ad-7c47-487d-ba6a-9456765823f7

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

October 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-