NEURODX DEVELOPMENT LLC

Address:115 E Ferry Rd,Yardley,PA,19067,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Shunt, Central Nervous System And Components (JXG) (3)

Premarket Exempt

Clear

ShuntCheck III Software - 00865435000311 Catalog Number : SCIII SW

Device Description : ShuntCheck software - Installed on Windows computer; guides user through test pr ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph

Device Class : 2

Duns Number: 828682240

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

ShuntCheck III DAQ - 00865435000328 Catalog Number : DAQ-1

Device Description : Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windo Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor

Device Class : 2

Duns Number: 828682240

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

ShuntCheck Test Pack - 00865435000335 Catalog Number : TP-1

Device Description : ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pa ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a skin marker in a clamshell container

Device Class :

Duns Number: 828682240

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

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