Catalog Number

-

Brand Name

n.a.

Version/Model Number

65-00-090

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 10, 2022

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

-

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

e1172dec-5cd1-43e6-81cb-aefaad4e39f7

Public Version Date

February 11, 2022

Public Version Number

3

DI Record Publish Date

September 18, 2020

Package DI Number

14250105600565

Quantity per Package

10

Contains DI Package

04250105600568

Package Discontinue Date

February 09, 2022

Package Status

Not in Commercial Distribution

Package Type

-