Catalog Number

H938G792

Brand Name

EXACTAMIX

Version/Model Number

H938G792

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

e1136107-e5d6-40d0-adea-38808544847c

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

50085412492006

Quantity per Package

10

Contains DI Package

00085412492001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE