Catalog Number

-

Brand Name

Bivona

Version/Model Number

AT12HS45NSA030S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2016

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K923878

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

f63182af-238b-4bb1-b53b-8bb81d661e78

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

July 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-