Plasma Control - MassCheck® Benzodiazepines1 , Plasma Control - Chromsystems Instruments + Chemicals GmbH

Duns Number:328712260

Device Description: MassCheck® Benzodiazepines1 , Plasma Control Level II

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More Product Details

Catalog Number

0239

Brand Name

Plasma Control

Version/Model Number

0239

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

LAS

Product Code Name

Drug Specific Control Materials

Device Record Status

Public Device Record Key

a6f31da7-bb38-4f06-8841-3645525f2145

Public Version Date

August 07, 2020

Public Version Number

1

DI Record Publish Date

July 30, 2020

Additional Identifiers

Package DI Number

04250317524157

Quantity per Package

5

Contains DI Package

04250317545275

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