DoVac Elite

GUDID 00867268000407

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.

IT SYNERGISTICS, LLC

Blood bank information system application software

• Primary Device ID: 00867268000407
• NIH Device Record Key: 96ec54a9-9e96-43ec-9cbc-36e4dfbaed20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DoVac Elite
• Version Model Number: 2.0
• Company DUNS: 013847849
• Company Name: IT SYNERGISTICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-866-7648
• Email: itsy@itsynergitics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867268000407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK140091

FDA Product Code

• MMH: Blood Establishment Computer Software And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-12

Devices Manufactured by IT SYNERGISTICS, LLC

• 00867268000421 - bexWISE API: 2025-04-16 The bexWISE API (v1.0) is for use in blood establishments to facilitate communication between 510(k) cleared Blood Establishment
• 00867268000407 - DoVac Elite: 2018-07-06The 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.
• 00867268000407 - DoVac Elite: 2018-07-06 The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection proc
• 00867268000414 - LifeTec Elite: 2018-07-06 The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and