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SunMed LLC

SUNMED, LLC · Model 5807F-SE · UDI-DI 10889483553619

BYX Prescription
10
510(k) clearances
518
Adverse events (14 deaths)
1
Recalls
230
Facilities

Description

Pediatric, Noon-intubated, 7ft Oral/Nasal with Oxygen Tubing

Recalls

DateFirmReason
2018-08-10A M Systems IncSome of the Disposable Smooth Interior Tubing may pull apart when stretched.

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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.