Catalog Number

C-61203D

Brand Name

DrugSmart Cup

Version/Model Number

C-61203D

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2018

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082898

Product Code

DIS

Product Code Name

Enzyme Immunoassay, Barbiturate

Public Device Record Key

2a96deb2-192b-455c-98d1-22701b8d85f9

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-