Catalog Number

311.100

Brand Name

AccuMix® Mixing System

Version/Model Number

311.100

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

Yes

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

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

3deca2d5-571c-49fb-a0f1-46be9f754d0c

Public Version Date

October 18, 2022

Public Version Number

4

DI Record Publish Date

June 02, 2016

Package DI Number

00889024406520

Quantity per Package

4

Contains DI Package

00889024406452

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-