| Primary Device ID | 00867268000421 |
| NIH Device Record Key | c6616499-2d99-4035-9823-37e7a6d1f4ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | bexWISE API |
| 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 |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com | |
| Phone | 855-866-7648 |
| itsy@itsynergistics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867268000421 [Primary] |
| MMH | Blood Establishment Computer Software And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-16 |
| Device Publish Date | 2025-04-08 |
| 00867268000421 - bexWISE API | 2025-04-16The bexWISE API (v1.0) is for use in blood establishments to facilitate communication between 510(k) cleared Blood Establishment Computer Systems (BECS), allowing the exchange of donor and donation-related data used to determine donor eligibility and donation suitability. |
| 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 | 2018-07-06 The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and |