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U.S. Department of Health and Human Services

Product Classification

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Device low dead space needle, single lumen, hypodermic
Regulation Description Hypodermic single lumen needle.
Definition A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.
Physical State A low dead space needle consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub). The needle hub or connector of the needle is designed to reduce medication waste.
Technical Method Low dead space needles are operated manually by attaching it to a piston syringe.
Target Area Target injection sites may include subcutaneous, intramuscular, intravascular, intradermal, ophthalmic.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQNS
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 880.5570
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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