Device classification

Cabinet, Ethylene-Oxide Gas Aerator

General Hospital · 21 CFR 880.6100

Class IIProduct code FLI
Open FDA's page for this record
Third party flag
Y
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
FLI
Review panel
HO
Medical specialty
HO
Device name
Cabinet, Ethylene-Oxide Gas Aerator
Medical specialty description
General Hospital
Device class
2
Regulation number
880.6100
Implant flag
N
Submission type ID
1
Harmonized identifiers (openFDA)
K number
K761341, K781484, K904921, K830165, K813201, K902906, K831595, K790677
Registration number
3031841433, 3042272797
FEI number
3031841433, 3042272797
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.