WellSky Transfusion - WellSky™ Transfusion 2018 is a Blood - WELLSKY CORPORATION

Duns Number:177240249

Device Description: WellSky™ Transfusion 2018 is a Blood Establishment Computer Software Product. Other than t

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More Product Details

Catalog Number

-

Brand Name

WellSky Transfusion

Version/Model Number

2018

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

BK160066

Product Code Details

Product Code

MMH

Product Code Name

Blood Establishment Computer Software And Accessories

Device Record Status

Public Device Record Key

9e0b9789-a157-4651-b4fe-8f5ee4bf6712

Public Version Date

April 06, 2020

Public Version Number

3

DI Record Publish Date

September 14, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELLSKY CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8