Singapore HSA registration DE0016324
ICU Neutron Connector
Singapore·CLASS B·ICU Medical Inc.·Registered September 12, 2014Device 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 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.
Product Owner
- Name
- ICU Medical Inc.
- 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)
- Neutron™ Neutron™ w/Red Ring
- Model Identifier(s)
- 011-NC100 011-NC100-RR
About this record
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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