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NDDR and CDCS

CIELOWORKS, INC. · Model 2.3 · UDI-DI 00860011763208

MMH Prescription
0
510(k) clearances
1,040
Adverse events (9 deaths)
2
Recalls
45
Facilities

Description

NDDR and CDCS is a web-based application that is intended to meet the needs of participating donation centers to check for the presence of recent blood or blood components (including plasma) donations at other donation centers by a prospective donor, as well as check if prospective donors have been deferred by participating donation centers.

Recalls

DateFirmReason
2018-04-25ConvaTec, IncIt was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.
2010-06-22SCC Soft ComputerSCC Soft Computer is issuing a Correction for SoftBank II Versions: 23.1.2.x, 23.2.0.x, and 25.0.0.x software applications. Functionality issue - For clients generating patient hi

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.