FLIClass II
Cabinet, Ethylene-oxide Gas Aerator
General Hospital · 21 CFR 880.6100
MDR events7All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances8All time
Recent MDR events
7 adverse event reports on file
- 3M STERI-GAS EO CARTRIDGESSep 5, 2012Injury3m Healthcare2110898-2012-00032
- 3M STERI-GAS EO GAS CARTRIDGEOct 27, 2011Injury3m Health Care2110898-2011-00107
- STERI-GAS, STERI-VACJan 18, 2002Malfunction3m2110898-2002-00003
- STERI-GAS 4-100 CARTRIDGESep 19, 2000Malfunction3m2110898-2000-00013
- STERI-GAS 4-100Sep 12, 2000Malfunction3m Co.2110898-2000-00011
- STERI-GAS 4-100 CARTRIDGEMay 19, 2000Malfunction3m Co.2110898-2000-00004
- STERI-GAS 4-100 CARTRIDGEJan 21, 2000Malfunction3m Co.2110898-2000-00003
Event type breakdown
Malfunction5
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- 3M Health Care, Ltd.Dec 5, 1990
K904921 · STERI-VAC(TM) AERATOR MODEL XL
- Gas-VakOct 15, 1990
K902906 · GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR
- Castle Co.Jun 15, 1983
K831595 · CASTLE MODEL 3341 & 3441 & 4141 GAS AER
- Bear Medical Systems, Inc.Apr 12, 1983
K830165 · BEAR JET 150 VENTILATOR
- Sybron Corp.Dec 31, 1981
K813201 · CASTLE #3241 GAS AERATOR
- Castle Co.May 7, 1979
K790677 · EO EVACUATING SYSTEM I
- Castle Co.Oct 27, 1978
K781484 · CASTLE MODEL 3146 GAS AERATOR
- Amsco Co.Feb 28, 1977
K761341 · PORTAGAS AERATOR