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U.S. Department of Health and Human Services

Product Classification

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Device set, i.v. fluid transfer
Regulation Description Intravascular administration set.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeLHI
Premarket Review Office of 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
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Documents
Third Party Review
Accredited Persons
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