FDA Device Intelligence
HomeSUNSET HEALTHCARE SOLUTIONS, INC. › Oxygen Kit

Oxygen Kit

SUNSET HEALTHCARE SOLUTIONS, INC. · Model RESO2KITAU · UDI-DI 00848530105396

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

Description

O2 Starter Kit This kit contains: (2) RES1107S, (1) RES3025G, (1) RES018, (1) RES050, (1) HUM008, (1) RES2100, (1) RES037, (1) RES003

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.

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.