FDA Device Intelligence
Home › Device types › KGB

Mask, Oxygen, Non-Rebreathing

FDA product code KGB · Class 1 · Anesthesiology

548
Registered devices
159
Adverse events
8
Recalls
13
510(k) clearances

Devices with this code

RUSCH — TELEFLEX INCORPORATEDFlo2Max Oxygen Mask, Child — B.L.S. Systems Limited8930 MASK — HANS RUDOLPH, INC.O2 Cannula, 10 Clear Pediatric, 7' Tubing — ACCUTRON, INC.7450 RV2 MASK — HANS RUDOLPH, INC.Tavish — Canadian Hospital Specialties LimitedPocket Mask O2, HC White Private Label — Laerdal Medical AS7400 RV2 MASK — HANS RUDOLPH, INC.HUDSON RCI — MEDLINE INDUSTRIES, INC.7450 RV2 MASK — HANS RUDOLPH, INC.7450 RV2 MASK — HANS RUDOLPH, INC.7450 RV2 MASK — HANS RUDOLPH, INC.8930 MASK — HANS RUDOLPH, INC.6450 RV2 MASK — HANS RUDOLPH, INC.n/a — SALTER LABS6450 RV2 MASK — HANS RUDOLPH, INC.7450 RV2 MASK — HANS RUDOLPH, INC.7450 RV2 MASK — HANS RUDOLPH, INC.Medline — MEDLINE INDUSTRIES, INC.Curaplex — BOUND TREE MEDICAL, LLCPediatric Three-In-One Mask — Canadian Hospital Specialties Limited7450 RV2 MASK — HANS RUDOLPH, INC.Non-breathing Oxygen Mask with 7FT Saflo Oxygen Supply Tubing — Canadian Hospital Specialties LimitedHUDSON RCI — TELEFLEX INCORPORATED

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.

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