Substantially Equivalent 510(k) Device Information
Applicant: Information Data Management, Inc. Rosemont, IL
510(k) number: BK950045
Product: Donor Management Information Systems, vers.1.2
Date: 08/26/96
Summary of Safety and Effectiveness
CLASSIFICATION NAME:
Software, Blood-Bank, Stand Alone Products, Products Code 75MMH
PRODUCT TRADE NAME:
Donor Management Information System
COMMON NAME:
DMIS
PREDICATE DEVICE:
The DMIS system is substantially equivalent to the Donor Deferral Register, a computerized national blood donor deferral registry system. This system was being marketed by the American National Red Cross in May, 1975 as evidenced by a JAMA article.
DEVICE DESCRIPTION:
The DMIS system is a stand-alone blood bank software device which aids in the manufacture of blood and blood components.
INTENDED USE:
The DMIS system is a computerize system intended to be used by trained personnel as an aid in the tracking of the donor demographic information and test results as well as donor deferral information. This system has been on the market since 1991.
TECHNOLOGICAL CHARACTERISTICS:
The DMIS system is technologically similar to the Donor Deferral Register System and both devices accomplish the same intended use.
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