Device typeBlood/blood culture specimen transfer spike IVD, manual: A hand-held manual device intended to be used to obtain a specimen of blood, blood components (e.g., platelets), or blood culture from a specimen receptacle, and facilitate its transfer to another receptacle [e.g., evacuated blood collection tube] for subsequent analysis. It consists of a spike/needle for sampling the specimen through the sealed stopper of the receptacle (i.e., without opening the receptacle), and is designed to reduce the risk of user exposure to the specimen and spike/needle [e.g., has a plastic housing for guarding the needle]. This is a single-use device.
FDA categoryPipette, Quantitative, Hematology
Device IDM52536110
Single useYes
MRI safetyLabeling does not contain MRI Safety Information