DEVICE: Regulated Software Application (RSA) (00860664000309)

Download: XML | JSON

Device Identifier (DI) Information

Regulated Software Application (RSA)
1.0.19.0
1.0.19.0
ONEBLOOD, INC.
00860664000309
GS1
1
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.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Blood bank information system application software An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute administrative and clinical data within blood-bank centres. It accumulates data on blood-donor status and may include algorithms to process blood-bank information. It may perform additional tasks such as autologous and direct unit tracking, cross-match result determination, and/or management of bar-code information and patient history reports. It is typically supplied for installation into a blood bank information system, or mainframe or decentralized computers/networks.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MMH Software, Blood Bank, Stand Alone Products
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 14, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
18889366283
RSAsupportEX@oneblood.org
CLOSE