Device classification

Apparatus, Hemoperfusion, Sorbent

Gastroenterology, Urology · 21 CFR 876.5870

Class IIProduct code FLD
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Ineligible
Product code
FLD
Review panel
GU
Medical specialty
GU
Device name
Apparatus, Hemoperfusion, Sorbent
Medical specialty description
Gastroenterology, Urology
Device class
2
Regulation number
876.5870
Implant flag
N
Submission type ID
1
Harmonized identifiers (openFDA)
K number
K885017, K984546, K840532, K873643, K831029, K133807, K992196, K953751, K113313, K971015, K033262
Registration number
3038195011, 9611369, 1319660, 3014015528, 3011228909, 2245304, 3030956240, 3032828299, 1319639, 2183828, 3006174295, 3008822486
FEI number
3002807035, 1000136478, 3038195011, 3014015528, 1000138054, 3011228909, 2245304, 3030956240, 3032828299, 2183828, 3006174295, 3008822486
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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.