Catalog Number

0335

Brand Name

Opiate 2000 DAU Calibrator, High Calibrator

Version/Model Number

0335

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K120761

Product Code

DLJ

Product Code Name

Calibrators, Drug Specific

Public Device Record Key

14d4b132-d389-4a2f-9b30-66b3748e4924

Public Version Date

August 24, 2018

Public Version Number

4

DI Record Publish Date

July 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-