Home › Device types › BYF
Mask, Oxygen, Low Concentration, Venturi
FDA product code BYF · Class 1 · Anesthesiology
227
Registered devices
30
Adverse events
3
Recalls
19
510(k) clearances
Devices with this code
Venticaire Lite — FLEXICARE MEDICAL LIMITEDVenturi valv. kit O2Star fixed — Drägerwerk AG & Co. KGaAVenticaire Lite — FLEXICARE MEDICAL LIMITEDVenticaire Lite — FLEXICARE MEDICAL LIMITEDVenticaire Lite — FLEXICARE MEDICAL LIMITEDVenticaire Lite — FLEXICARE MEDICAL LIMITEDHEADSTAR — HEADSTAR MEDICAL PRODUCTS CO., LTD.Mask ventkit O2Star adjust S — Drägerwerk AG & Co. KGaAVenticaire Lite — FLEXICARE MEDICAL LIMITEDRUSCH — TELEFLEX INCORPORATEDSafetyNeb — GROMAN INC.CPAP Kit — SUNSET HEALTHCARE SOLUTIONS, INC.VENTURI VALVE 40% OXYGEN, RED — Intersurgical IncorporatedVenticaire Lite — FLEXICARE MEDICAL LIMITED35% OXYGEN VENTURI VALVE — Intersurgical IncorporatedVenticaire Lite — FLEXICARE MEDICAL LIMITEDVenticaire Lite — FLEXICARE MEDICAL LIMITEDEMSRUN — Wuxi Emsrun Technology Co., Ltd.Venticaire Lite — FLEXICARE MEDICAL LIMITEDn/a — SALTER LABSVenticaire Lite — FLEXICARE MEDICAL LIMITEDVenticaire Lite — FLEXICARE MEDICAL LIMITEDVenticaire Lite — FLEXICARE MEDICAL LIMITEDCPAP Kit — SUNSET HEALTHCARE SOLUTIONS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-03-25 | Salter Laboratories, Division of Regulatory Affairs | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respira |
| 2011-02-11 | Smiths Medical | A sticky substance on the inside and/ or outside of the Mask |
| 2011-02-11 | Smiths Medical | A sticky substance on the inside and/ or outside of the Mask |
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