IT SYNERGISTICS, LLC

Address:115 Tree St,Flowood,MS,39232,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Blood Establishment Computer Software And Accessories (MMH) (2)

Premarket Exempt

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DoVac Elite - 00867268000407 Catalog Number :

Device Description : The DoVac Elite system is a web-based application that provides functions for ma The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection process. The system identifies results and responses throughout the process that can be considered ‘high-risk’ to the general blood supply which notifies and allows a staff member to complete a review to determine donor suitability. The DoVac Elite application is capable of capturing all information in the collection process: registration, physical exam, computer assisted medical questionnaire, donor consent, donation identification number assignment, phlebotomy, supervisor review and audit. The system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions.

Device Class : 2

Duns Number: 013847849

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

LifeTec Elite - 00867268000414 Catalog Number :

Device Description : The LifeTec Elite system is a blood establishment computer system that receives The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and blood components, which blood establishments rely on for making decisions regarding the release of blood components for transfusion or further manufacturing. Specifically, laboratory testing, product manufacturing and inventory control/distribution.