Catalog Number

-

Brand Name

NA

Version/Model Number

NA

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

b34fb0d7-cb01-463a-9779-48316e68e5a9

Public Version Date

February 10, 2020

Public Version Number

4

DI Record Publish Date

November 15, 2017

Package DI Number

16948538362089

Quantity per Package

60

Contains DI Package

06948538362082

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-