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Mask, Oxygen, Non-Rebreathing

FDA product code KGB · Class 1 · Anesthesiology

549
Registered devices
175
Adverse events
8
Recalls
13
510(k) clearances

Devices with this code

7920 MASK — HANS RUDOLPH, INC.Adult Non-Rebreather Oxygen Mask w/ 7ft safety tubing - High Concentration — SUNSET HEALTHCARE SOLUTIONS, INC.7950 MASK — HANS RUDOLPH, INC.7450 RV2 MASK — HANS RUDOLPH, INC.8960 MASK — HANS RUDOLPH, INC.7450 RV2 MASK — HANS RUDOLPH, INC.7450 RV2 MASK — HANS RUDOLPH, INC.Mediox — Mediox Medical Service Ltd8900 MASK — HANS RUDOLPH, INC.7970 MASK — HANS RUDOLPH, INC.Face mask - Pediatric — Canadian Hospital Specialties LimitedAdult 3 IN 1 Mask — Canadian Hospital Specialties Limited8920 MASK — HANS RUDOLPH, INC.Venticaire Lite — FLEXICARE MEDICAL LIMITEDCuraplex — BOUND TREE MEDICAL, LLCResponsive Respiratory — RESPONSIVE RESPIRATORY, INC.Tavish — Canadian Hospital Specialties LimitedPocket Mask O2, HC White Private Label — Laerdal Medical AS7400 RV2 MASK — HANS RUDOLPH, INC.MedSource Face Shield — MEDSOURCE INTERNATIONAL LLC7400 RV2 MASK — HANS RUDOLPH, INC.7450 RV2 MASK — HANS RUDOLPH, INC.HUDSON RCI — MEDLINE INDUSTRIES, INC.8950 MASK — HANS RUDOLPH, INC.

Recent recalls

DateFirmReason
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making
2004-07-12Medex IncThe non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
2004-07-12Medex IncThe non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.

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