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U.S. Department of Health and Human Services

Product Classification

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Device low dead space piston syringe
Regulation Description Piston syringe.
Definition A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.
Physical State A low dead space syringe consists of a syringe barrel, a plunger, and may include a needle. The plunger and barrel are typically made of a polymeric material whereas the needle is made from stainless steel. The syringe plunger, syringe nozzle and/or needle of the syringe is designed to reduce medication waste.
Technical Method Low dead space syringes are operated manually by pushing or pulling the plunger to expel or withdraw a liquid.
Target Area Target injection sites may include subcutaneous, intramuscular, intravascular, intradermal and intravitreal.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQNQ
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 880.5860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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