WellSky Transfusion - WellSky Transfusion 2022 is a Blood Establishment - WELLSKY CORPORATION

Duns Number:177240249

Device Description: WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than th WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.There is no hardware or other components included in the final product.WellSky Transfusion 2022 is intended to address allphases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive andtest patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)WellSky Transfusion 2022 provides customized control processes for transfusion management of all procedures andtesting on products and patients to reduce human error and enhance the ability to assure patient and product safety.

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More Product Details

Catalog Number

-

Brand Name

WellSky Transfusion

Version/Model Number

2022

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

c7fa4df9-fe59-49c3-a564-1c42e1e5a087

Public Version Date

February 18, 2022

Public Version Number

1

DI Record Publish Date

February 10, 2022

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