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ICU Neutron Connector - HSA Registration DE0016324

Access comprehensive regulatory information for ICU Neutron Connector in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016324 and owned by ICU Medical Inc.. The device was registered on September 12, 2014.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0016324
ICU Neutron Connector
HSA Registration Number: DE0016324
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Product Description

Intended for use as an accessory to an intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. The device may also be used with power injector procedures up to 10mL per second of contrast media and a maximum pressure of 350psi.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDB00110
HS Code
90183990
Registration Information
Registration Number
DE0016324
Registration Date
September 12, 2014
Change Notification Approval Date
January 13, 2022
Retention Due Date
September 11, 2025
Product Owner
Short Name
ICU Medical Inc.
Address
951 Calle Amanecer San Clemente, CA 92673, UNITED STATES
Registrant
Address
65 UBI ROAD 1, OXLEY BIZHUB, #04-30, SINGAPORE 408729
Importer
Address
65 UBI ROAD 1, OXLEY BIZHUB, #04-30, SINGAPORE 408729
Model Information
Model Name(s)
Neutronโ„ข Neutronโ„ข w/Red Ring
Model Identifier(s)
011-NC100 011-NC100-RR