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U.S. Department of Health and Human Services

Product Classification

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Device non-coring (huber) needle
Regulation Description Hypodermic single lumen needle.
Definition The non-coring needle (huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.
Physical State Sterile medical grade stainless steel hollow needle which may be straight or bent at a 90 degrees, with a hub that is only compatible with other luer type devices. The needle tip angles so the bevel opening provides a clean entry into the port’s septra without damage. The hub may include; an anti-stick safety feature, integrated extension set, or luer activated valve.
Technical Method A sterile non-coring (Huber) needle used under sterile conditions to pierce the skin above a subcutaneous implanted intravascular infusion port. Once the port is accessed, the needle is pushed through the septum into the port reservoir body that has an integrated catheter.
Target Area Various subcutaneous locations; upper arms, chest and abdomen. Indirectly effects the central venous vascular system by facilitating the delivery of intravenous fluids, medications, contrast media and the withdrawal of blood for laboratory sampling.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePTI
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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