Catalog Number

H93865

Brand Name

EXACTAMIX

Version/Model Number

H93865

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 25, 2016

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

K900585,K900585

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

5b4f97b8-1f0a-4e56-8fd5-17385269ca6d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

50085412476709

Quantity per Package

50

Contains DI Package

00085412476704

Package Discontinue Date

September 25, 2016

Package Status

Not in Commercial Distribution

Package Type

CASE