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510(k) Data Aggregation
K Number
K191258Device Name
Intraosseous infusion device
Manufacturer
Date Cleared
2019-10-23
(166 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Einstein Works, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NIO-P for pediatric is intended to provide Intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients in age 3-12 years of age.
Device Description
The Einstein Works NIO Pediatric (NIO- P) Intraosseous Infusion Device permits intraosseous access through the Proximal Tibia and the Humeral Head. The NIO device is comprised of a trocar needle, spring, piston and housing and it resembles a syringe. When activated, a loaded spring is released, and the device injects the needle to a predetermined depth into the bone marrow cavity. The NIO device also features the same safety latch and trigger mechanism which is found with the predicate device.
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