WellSky Transfusion

GUDID B105TRANSFUSION2020

WellSky Tranfusion 2020 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 2020 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 (bi-directional) WellSky Transfusion 2020 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 IDB105TRANSFUSION2020
NIH Device Record Keye52b6ca0-22f9-4aea-b070-614ffa89c121
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellSky Transfusion
Version Model Number2020
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB105TRANSFUSION2020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-02-17
Device Publish Date2021-02-09

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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