FDA Device Intelligence
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Valve, Non-Rebreathing

FDA product code CBP · Class 2 · Anesthesiology

761
Registered devices
55
Adverse events
7
Recalls
103
510(k) clearances

Devices with this code

WNL — FOREMOUNT ENTERPRISE CO., LTD.n/a — HANS RUDOLPH, INC.One Pacific — FOREMOUNT ENTERPRISE CO., LTD.Rescuer — B.L.S. Systems LimitedPocket Mask O2, HC White Private Label — Laerdal Medical ASCuraplex — BOUND TREE MEDICAL, LLCCompower — XIAMEN COMPOWER MEDICAL TECH. CO., LTDWNL — FOREMOUNT ENTERPRISE CO., LTD.Code One — FOREMOUNT ENTERPRISE CO., LTD.LSP — Allied Medical, LLC16PW - PG&E - Poly White — Certified Safety Manufacturing, Inc.Rescuer CPR Facemask with O2, head strap, One way Valve in Hard Shell Case — B.L.S. Systems LimitedCuraplex — BOUND TREE MEDICAL, LLCEmergency Rescue Mask — CBX LLCCPRotector® - w/Nitrile Gloves - Overwrap — Certified Safety Manufacturing, Inc.n/a — HANS RUDOLPH, INC.n/a — HANS RUDOLPH, INC.2700 NRBV — HANS RUDOLPH, INC.Curaplex — BOUND TREE MEDICAL, LLCPocket Mask,SP (Blue,IE) — Laerdal Medical ASFaceshield with one way valve, glove, wipe in pouch — B.L.S. Systems LimitedTop Safety — FOREMOUNT ENTERPRISE CO., LTD.N/A — Intersurgical Incorporated(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves — RONDEX PRODUCTS, INCORPORATED

Recent recalls

DateFirmReason
2016-05-16Lifeline First Aid LLCFirst aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for p
2016-05-16Lifeline First Aid LLCCadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescriptio
2014-07-02Dynarex Corporation"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
2004-02-03Rusch IncValve cap may become loose and enter the air circuitry.
2004-02-03Rusch IncValve cap may become loose and enter the air circuitry.
2004-02-03Rusch IncValve cap may become loose and enter the air circuitry.
2004-02-03Rusch IncValve cap may become loose and enter the air circuitry.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.