Catalog Number

5039-0002-00

Brand Name

ARK™ Meperidine Calibrator

Version/Model Number

5039-0002-00

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DLJ

Product Code Name

Calibrators, Drug Specific

Public Device Record Key

877c100b-fa66-4450-a297-bb3d8be7b8d3

Public Version Date

July 30, 2019

Public Version Number

1

DI Record Publish Date

July 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-