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Pulmonary Filtration Technologies

WHITE CARDIOPULMONARY, INC. · Model 7400PFT · UDI-DI 10868750000216

BZG Prescription
10
510(k) clearances
31
Adverse events
1
Recalls
94
Facilities

Description

10868750000216 = basePkg; 20868750000213 = higherPkg1 - contains 100 of the base package Primary DI inside it; 30868750000210 = higherPkg2 - contains 4 of the higherPkg1 inside it. Disposable bacterial/viral filter for pulmonary function testing - green

Recalls

DateFirmReason
2024-10-11Baxter Healthcare CorporationThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.