Home › Device types › BYF
Mask, Oxygen, Low Concentration, Venturi
FDA product code BYF · Class 1 · Anesthesiology
224
Registered devices
27
Adverse events
3
Recalls
19
510(k) clearances
Devices with this code
Venticaire Lite — FLEXICARE MEDICAL LIMITED35% OXYGEN VENTURI VALVE — Intersurgical IncorporatedVenticaire Lite — FLEXICARE MEDICAL LIMITEDHUDSON RCI — TELEFLEX INCORPORATEDVenticaire Lite — FLEXICARE MEDICAL LIMITEDVenticaire Lite — FLEXICARE MEDICAL LIMITEDCPAP Kit — SUNSET HEALTHCARE SOLUTIONS, INC.HUDSON RCI — TELEFLEX INCORPORATEDAerosol & Nebs — SUNSET HEALTHCARE SOLUTIONS, INC.Venticaire Lite — FLEXICARE MEDICAL LIMITEDINTERSURGICAL ECOLITE, ADULT, OXYGEN MASK WITH 31% VENTURI VALVE, ORANGE — Intersurgical IncorporatedHEADSTAR — HEADSTAR MEDICAL PRODUCTS CO., LTD.50% OXYGEN VENTURI VALVE — Intersurgical IncorporatedCPAP Kit — SUNSET HEALTHCARE SOLUTIONS, INC.Venticaire Lite — FLEXICARE MEDICAL LIMITEDHUDSON RCI — TELEFLEX INCORPORATEDn/a — SALTER LABSVenticaire Lite — FLEXICARE MEDICAL LIMITEDMULTIOX, ECO, PAEDIATRIC, ADJUSTABLE VENTURI MASK KIT — Intersurgical IncorporatedHUDSON RCI — TELEFLEX INCORPORATEDN/A — SALTER LABSPortex — ICU MEDICAL, INC.Venticaire Lite — FLEXICARE MEDICAL LIMITEDVenticaire Lite — FLEXICARE MEDICAL LIMITED
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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