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 WellSky™ Transfusion 2018 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 2018 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage devices (bi-directional)WellSky™ Transfusion 2018 provides customized control processes for transfusion management of all procedures and testing 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

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