MODClass II

Accessory To Continuous Ventilator (respirator)

Anesthesiology · 21 CFR 868.5895

MDR events19All time

Recalls1All time

Registered firms8Currently listed

510(k) clearances14All time

Recent MDR events

19 adverse event reports on file

Event type breakdown

Malfunction15

Injury2

Death1

Other1

Most-reported manufacturers

Unspecified9 Bio-med Devices1 Car-go-denver1 Cardiopulmonary Corp1 Cardiopulmonary Corp.1 Carefusion1 Cpc (vendor)1 Depuy Orthopaedics Inc Us1

Recalls

1 recall events for this product code

Medical Device Group Inc.
TerminatedAug 16, 2005
Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002). Sterile. Single Use.
Device separation presenting a choking hazard.
Z-1371-05 · View FDA record ↗

Registered firms

8 firms currently registered for this product code

510(k) clearances

14 clearances for this product code