Catalog Number

-

Brand Name

Connecting Tube for Manujet III

Version/Model Number

54-05-111

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"

Yes

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

-

Product Code

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Public Device Record Key

35d15345-e85f-45ec-b637-478c17842ae5

Public Version Date

May 20, 2021

Public Version Number

5

DI Record Publish Date

May 13, 2016

Package DI Number

14250105604280

Quantity per Package

10

Contains DI Package

04250105604283

Package Discontinue Date

April 14, 2021

Package Status

Not in Commercial Distribution

Package Type

-