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510(k) Data Aggregation
K Number
K211395Device Name
NIO-I
Manufacturer
Date Cleared
2021-07-28
(84 days)
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Einstein Works LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NIO-I is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.
Device Description
The NIO-I is a manual intraosseous device. It includes a lightweight ergonomic handle for easy and fast manual insertion of the needle into the medullary cavity. The device is designed specifically for infants between 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age. The NIO-I provides haptic feedback via the steppedneedle design that helps preventing over-penetration into the distal cortex. After insertion of the needle, the user disconnects the handle and pulls out the trocar leaving the cannula inside the medullary cavity. Through the cannula, the caregiver can infuse fluids and drugs that will reach the vascular system.
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