Catalog Number

H938901

Brand Name

EXACTAMIX

Version/Model Number

H938901

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

K960581,K960581

Product Code

KPE

Product Code Name

CONTAINER, I.V.

Public Device Record Key

a12495a9-80d1-49c8-b65e-4ae9bb0ec215

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

50085412477461

Quantity per Package

42

Contains DI Package

00085412477466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE