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U.S. Department of Health and Human Services

Product Classification
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Device pediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injury
Definition For the treatment of acute kidney injury in pediatric patients, in conjunction with continuous kidney replacement treatment (CKRT).
Physical State Synthetic semipermeable membrane cartridge, tubing, connectors
Technical Method Using a cartridge with a semipermeable membrane, the system sequesters and inhibits activated leukocytes within the extracorporeal circuit of a Continuous Kidney Replacement Treatment system that is using regional citrate anticoagulation (RCA).
Target Area Extracorporeal whole blood circulation
Review Panel Hematology
Product CodeQZV
Premarket Review CBER Division (CBER)
Submission Type HDE - Humanitarian Device Exemption
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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