WellSky Transfusion

GUDID B105TRANSFUSION2023

WellSky Transfusion 2023 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 2023 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 device (bidirectional) WellSky Transfusion 2023 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.

WELLSKY CORPORATION

Blood bank information system application software
Primary Device IDB105TRANSFUSION2023
NIH Device Record Keyc81979c1-35e0-439e-bc9e-86ff55b3dbf4
Commercial Distribution Discontinuation2023-12-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameWellSky Transfusion
Version Model Number2023
Company DUNS177240249
Company NameWELLSKY CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB105TRANSFUSION2023 [Primary]

FDA Product Code

MMHBlood Establishment Computer Software And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-14
Device Publish Date2023-12-06

On-Brand Devices [WellSky Transfusion]

B105TRANSFUSION20180WellSky™ Transfusion 2018 is a Blood Establishment Computer Software Product. Other than the p
B105TRANSFUSION20190WellSky Tranfusion 2019 is a Blood Establishment Computer Software Product. Other than the packa
B105TRANSFUSION2021WellSky Transfusion 2021 is a Blood Establishment Computer Software Product. Other than the pack
B105TRANSFUSION2020WellSky Tranfusion 2020 is a Blood Establishment Computer Software Product. Other than the packa
B105TRANSFUSION0WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than the pack
B105TRANSFUSION2023WellSky Transfusion 2023 is a Blood Establishment Computer Software Product. Other than the pack
B105TRANSFUSION20240WellSky Transfusion 2024 is a Blood Establishment Computer Software Product. Other than the pack

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