Home › Device types › BYG
Mask, Oxygen
FDA product code BYG · Class 1 · Anesthesiology
1,140
Registered devices
542
Adverse events
41
Recalls
55
510(k) clearances
Devices with this code
MedSource Tracheostomy Mask — MEDSOURCE INTERNATIONAL LLCVentlab — VENTLAB, LLCCreate Biotech — CREATE BIOTECH CO., LTD.AirLife™ — AIRLIFEAdult NSA Oxygen Mask — Canadian Hospital Specialties LimitedOxygen Mask — Well Lead Medical Co.,LtdVentlab — VENTLAB, LLC7301 EAGLE1 — HANS RUDOLPH, INC.N/A — SALTER LABSHUDSON RCI — TELEFLEX INCORPORATEDN/A — SALTER LABSVentlab — VENTLAB, LLCVentlab — VENTLAB, LLCAdult Oxygen Mask Med. Concentration — Canadian Hospital Specialties LimitedAerogen®Go — HCMED INNOVATIONS CO., LTD.Curaplex — TRI-ANIM HEALTH SERVICES, INC.Oxygen Mask — Well Lead Medical Co.,Ltd7302 EAGLE2 — HANS RUDOLPH, INC.DeVilbiss — SUNMED, LLCAirLife™ — SUNMED, LLC7302 EAGLE2 — HANS RUDOLPH, INC.7301 EAGLE1 — HANS RUDOLPH, INC.Curaplex — BOUND TREE MEDICAL, LLCN/A — SALTER LABS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-21 | Medline Industries, LP | Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may |
| 2018-07-11 | POM Medical LLC | Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a c |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The f |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc |
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