ADIMS

GUDID 00860007397615

ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs

Csl Plasma Inc.

Blood bank information system application software
Primary Device ID00860007397615
NIH Device Record Key8758f82a-026d-4b16-8c43-95181ce6ca80
Commercial Distribution StatusIn Commercial Distribution
Brand NameADIMS
Version Model Number1.0
Company DUNS112132795
Company NameCsl Plasma Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
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
GS100860007397615 [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 Date2022-01-18
Device Publish Date2022-01-10

Devices Manufactured by Csl Plasma Inc.

00860007397615 - ADIMS2022-01-18ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs
00860007397615 - ADIMS2022-01-18 ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and w
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