Catalog Number

-

Brand Name

BlenderBuddy2

Version/Model Number

R233P04-001

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

K040484

Product Code

CCL

Product Code Name

Analyzer, Gas, Oxygen, Gaseous-Phase

Public Device Record Key

0becba92-5853-4b38-a99b-43a5757f21b6

Public Version Date

February 25, 2019

Public Version Number

1

DI Record Publish Date

January 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-