LifeTec Elite

GUDID 00867268000414

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.

IT SYNERGISTICS, LLC

Blood bank information system application software

• Primary Device ID: 00867268000414
• NIH Device Record Key: ff106c82-315c-42ed-a4cb-1bbde50b2e23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeTec Elite
• Version Model Number: 1.0
• 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@itsynergistics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867268000414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK060032

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: 2018-07-06 The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection proc
• 00867268000414 - LifeTec Elite: 2018-07-06The 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.
• 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