WellSky Blood - Emergency Issue

GUDID B105BLOOD2020

WellSky™ Blood – Emergency Issue 2020 R1 is a Blood Establishment Computer Software (BECS) Accessory that provides the ability to perform an Emergency Issue. WellSky Blood – Emergency Issue provides customized control processes for Emergency Issue management to reduce human error and enhance the ability to assure patient product safety. Functionality is provided for patient identification, support of emergency patient safety protocols, issue blood products under emergency conditions and confirmation scan of correct transfusion slip on correct unit. WellSky™ Blood – Emergency Issue 2020 R1 can be used to emergency issue products on a mobile device and desktop workstation. WellSky™ Blood – Emergency Issue 2020 R1 is not a standalone system. WellSky™ Blood Emergency Issue 2020 depends on HCLL™ Transfusion to obtain patient data, as well as to send unit information, safety data, and regulatory inspection step data back to HCLL™ Transfusion. will communicate bi-directionally through intelligent integration messages to obtain patient information and to update and record the Emergency Issue in HCLL™ Transfusion. HCLL™ Transfusion stores this information in the Transfusion database, exactly now Transfusion processes and stored this data currently. WellSky Blood Emergency Issue does not maintain data.

WELLSKY CORPORATION

Blood bank information system application software
Primary Device IDB105BLOOD2020
NIH Device Record Keyd82139ee-c191-4d4f-9032-676cdf7bb660
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellSky Blood - Emergency Issue
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
HIBCCB105BLOOD2020 [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 Date2020-06-23
Device Publish Date2020-06-15

Devices Manufactured by WELLSKY CORPORATION

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