Thermo Scientific - Thermo Scientific TSX Series high-performance - KEY SCIENTIFIC INC

Duns Number:938286804

Device Description: Thermo Scientific TSX Series high-performance blood bank refrigerator

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More Product Details

Catalog Number

TSX5004BZ

Brand Name

Thermo Scientific

Version/Model Number

TSX5004BZ

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

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Device Record Status

Public Device Record Key

e45865a8-d40b-402a-aace-aa8ce9e05939

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

May 14, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KEY SCIENTIFIC INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 255