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SALTER LABS · Model R126797 · UDI-DI 00607411919534

BYX Prescription
10
510(k) clearances
518
Adverse events (14 deaths)
1
Recalls
232
Facilities

Description

Nipple & Nut Standard diss 1240 oxygen fitting Single use. Do not sterilize. 4-24-2019...no barcode on current product. Remove from distribution.

Recalls

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

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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.