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U.S. Department of Health and Human Services

Product Classification

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Device administrations sets with neuraxial connectors
Regulation Description Intravascular administration set.
Definition The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Physical State The connector consists of a ISO 80369-6 compliant connection and may be composed of plastic.
Technical Method The neuraxial connector is attached to a small bore connector intended to be used for neuraxial applications and intended to facilitate in administration of medication or act as a transitional piece to be used with administration sets with a non ISO 80369-6 compliant connection.
Target Area The neuraxial space
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePWH
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
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
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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