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U.S. Department of Health and Human Services

Product Classification

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Device neuraxial administration set - intrathecal delivery
Definition Neuraxial Administration Sets used to deliver fluids to the intrathecal space.
Physical State Administration sets are made of polymers and connected to infusion pumps or medication containers such as syringes or flexible medication containers.
Technical Method Administration sets are made of polymers, are connected to infusion pumps or medication containers (i.e. syringes, flexible medication containers), and are used to deliver fluids from the storage container or pump into the intrathecal space. These sets may include ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial connectors.
Target Area intrathecal space
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePYR
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5440
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible