Catalog Number

H938G175

Brand Name

EXACTAMIX

Version/Model Number

H938G175

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

K002705,K002705

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

03166c16-e681-42cc-879c-faff8db9dc29

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

55413765492032

Quantity per Package

25

Contains DI Package

05413765492037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE