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Oxygen Kit

SUNSET HEALTHCARE SOLUTIONS, INC. · Model APRO100O2HOS · UDI-DI 00848530105297

OGL
0
510(k) clearances
13
Adverse events
1
Recalls
15
Facilities

Description

Oxygen Kit This kit contains: (3) RES1107S (2) RES3050G (1) RES050 (1) RES037 (1) HUM008 (2) RES010 (1) RES010TC (1) RES003 (1) RES3007G (1) RES012

Recalls

DateFirmReason
2011-10-17Vital Signs Devices, a GE Healthcare CompanyPovidone Iodine Pads included in the Vital Signs Broselow Pediatric Emergency Kit may be contaminated with Elizabethkinga meningoseptica.

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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.