Catalog Number

-

Brand Name

Newport

Version/Model Number

MXL70A-GR-DS

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K860373

Product Code

BZR

Product Code Name

Mixer, breathing gases, anesthesia inhalation

Public Device Record Key

9df5dc0a-b14d-4bae-845f-2829270003e1

Public Version Date

November 08, 2021

Public Version Number

2

DI Record Publish Date

September 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-