Catalog Number

-

Brand Name

io

Version/Model Number

Size:Large

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

-

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

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

0cbc1fcf-260a-4842-ae54-d87e1d1c0dc7

Public Version Date

February 10, 2020

Public Version Number

4

DI Record Publish Date

May 19, 2016

Package DI Number

16948538360115

Quantity per Package

20

Contains DI Package

06948538360118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-