Wash Solution A Concentrate - Wash Solution for use with the IH-500 - Bio-Rad Medical Diagnostics GmbH

Duns Number:312576506

Device Description: Wash Solution for use with the IH-500

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More Product Details

Catalog Number

-

Brand Name

Wash Solution A Concentrate

Version/Model Number

12012668

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

Yes

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

-

Product Code Details

Product Code

GIF

Product Code Name

Diluent, Blood Cell

Device Record Status

Public Device Record Key

7198a554-4bcc-4767-a6ce-f8655982ad08

Public Version Date

February 13, 2020

Public Version Number

1

DI Record Publish Date

February 05, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO-RAD MEDICAL DIAGNOSTICS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 38
U Unclassified 21