Catalog Number

96040

Brand Name

Urine Calibrator Set

Version/Model Number

96040

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

-

Prescription Use (Rx)

-

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

832dec77-47ce-4810-951e-4f4f50df3cd4

Public Version Date

December 10, 2019

Public Version Number

1

DI Record Publish Date

December 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-