Urine Control - MassCheck® Ethyl Glucuronide, Ethyl Sulfate, - Chromsystems Instruments + Chemicals GmbH

Duns Number:328712260

Device Description: MassCheck® Ethyl Glucuronide, Ethyl Sulfate, Urine Control Level III

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More Product Details

Catalog Number

0369

Brand Name

Urine Control

Version/Model Number

0369

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DKC

Product Code Name

Alcohol Control Materials

Device Record Status

Public Device Record Key

fa741399-314a-4ac7-bbfd-e6944d8ab7d3

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Additional Identifiers

Package DI Number

04250317535795

Quantity per Package

5

Contains DI Package

04250317546111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 455
2 A medical device with a moderate to high risk that requires special controls. 92