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Evolve Cell Culture Bag

ORIGEN BIOMEDICAL, INC. · Model EV120 + F-M12 · UDI-DI 10816203024074

KJA Prescription
10
510(k) clearances
2
Adverse events
1
Recalls
29
Facilities

Description

EVO Bag, 70-120ml Fill Volume, with luer connections and needle free valve with separate female to male tube set with 12cm of tubing

Recalls

DateFirmReason
2021-01-28OriGen Biomedical, Inc.It was identified that tissue culture bags were incorrectly labeled as free of phthalates.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.