Catalog Number

195.003.010

Brand Name

Eurotrol

Version/Model Number

195.003.010

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121467,K121467

Product Code

GLK

Product Code Name

Control, Hematocrit

Public Device Record Key

5a83f387-08a3-46ad-9aaa-779bdd5bb12d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-