Catalog Number

H93866

Brand Name

EXACTAMIX

Version/Model Number

H93866

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

K903159,K903159

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

b38fb177-2bf5-4b84-a16e-b003c70baf80

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

50085412476716

Quantity per Package

10

Contains DI Package

00085412476711

Package Discontinue Date

September 25, 2016

Package Status

Not in Commercial Distribution

Package Type

CASE