Catalog Number

H938G751

Brand Name

EXACTAMIX

Version/Model Number

H938G751

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

K903159,K903159

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

3196e317-40ba-47c2-ba06-a459b693f8c8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

50085412492051

Quantity per Package

25

Contains DI Package

00085412492056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE