Catalog Number

-

Brand Name

MaxBlend2

Version/Model Number

R229P01-020

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161718

Product Code

BZR

Product Code Name

Mixer, Breathing Gases, Anesthesia Inhalation

Public Device Record Key

40a84105-080b-401d-bc90-8b05e2c1c58a

Public Version Date

January 14, 2019

Public Version Number

4

DI Record Publish Date

December 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-