Catalog Number

700900VENT

Brand Name

900 Series Ventilator

Version/Model Number

700900VENT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

BSZ

Product Code Name

Gas-Machine, Anesthesia

Public Device Record Key

4030b375-93a9-4ee2-a886-ab3a77686c18

Public Version Date

June 19, 2019

Public Version Number

7

DI Record Publish Date

October 19, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-