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OXYGEN MASK ADULT, WITH 7FT TUBE,BULK PACKING
Model OM-81112 · BESMED HEALTH BUSINESS CORP. · DI 04716770811123
BYG — Mask, Oxygen · Class I · 21 CFR 868.5580
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-05
0
1
2021-06
0
1
2022-02
0
1
2022-03
0
2
2022-04
0
1
2022-08
0
2
2022-09
0
2
2023-01
0
2
2023-09
0
2
2024-02
0
3
2024-05
0
1
2024-07
0
2
2024-08
0
1
2024-09
0
2
2024-10
0
2
2024-11
0
3.33
2025-01
0
1.67
2025-04
0
2.67
2025-06
0
3
2025-09
0
2
2025-10
0
9
2025-12
0
4
2026-02
0
1.5
2026-04
0
5
2026-05
0
2.5
2026-06
0
2
This device (reports/month)Average device in BYG (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — BESMED HEALTH BUSINESS CORP.