Catalog Number

-

Brand Name

Bivona

Version/Model Number

60AFHXL60

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K081440

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

2d9431ac-1d5a-48b3-8c1c-4d8d48c401a6

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-