Catalog Number

5030500016

Brand Name

EXACTAMIX

Version/Model Number

E3050OD

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"

Yes

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

KPE

Product Code Name

Container, I.V.

Public Device Record Key

b762b031-f72f-4f6d-a399-2a3c5fba9a51

Public Version Date

October 05, 2022

Public Version Number

2

DI Record Publish Date

October 05, 2021

Package DI Number

18033718001006

Quantity per Package

30

Contains DI Package

08033718001009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-