Blood Typing Manager

Basic Information

• Brand Name: Blood Typing Manager
• Primary DI: 08436583731215
• Version / Model: 210404
• Catalog Number: 210404
• Company Name: DIAGNOSTIC GRIFOLS SA
• Labeler DUNS: 463625602
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-22
• Public Version: 1
• Public Version Date: 2023-08-30
• Public Version Status: New
• Public Device Record Key: 71b137c0-c754-4ec7-80d1-6aafeb1ad68b

Device Description

Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System, and aids users in Antibody Identification procedure. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System, and to aid users in Antibody Identification procedure as part of the DG Gel System.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMH	Blood Establishment Computer Software And Accessories	Hematology	864.9165	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44100	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08436583731215	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]