Regulated Software Application (RSA) 1.0.19.0

GUDID 00860664000309

The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of their blood banking processes. This system encapsulates the data access and business rules necessary for enabling blood collections, manufacturing, labeling, and distribution management efforts. Additionally, certain modules have associated administration function that creates traceability and accountability for every step of the blood banking process. The system utilizes technology standards that provide the robustness necessary for supporting web-enabled applications that interface with disparate systems. The application has been developed in a modular format.

ONEBLOOD, INC.

Blood bank information system application software

• Primary Device ID: 00860664000309
• NIH Device Record Key: 35ceda41-1f26-4d82-8123-2b9285ec89ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regulated Software Application (RSA)
• Version Model Number: 1.0.19.0
• Catalog Number: 1.0.19.0
• Company DUNS: 079208542
• Company Name: ONEBLOOD, INC.
• 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: true
• 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: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org
• Phone: 18889366283
• Email: RSAsupportEX@oneblood.org

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860664000309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK110048

FDA Product Code

• MMH: Software, Blood Bank, Stand Alone Products

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: 2016-09-14