Catalog Number

S0295

Brand Name

Oral Fluid 6-Acetylmorphine Calibrator, High Calibrator

Version/Model Number

S0295

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

K141205

Product Code

DLJ

Product Code Name

Calibrators, Drug Specific

Public Device Record Key

406c3f38-e353-421b-a446-ff1ff8c37b3a

Public Version Date

August 23, 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

-