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ICU Medical Microclave Connectors - HSA Registration DE0501828

Access comprehensive regulatory information for ICU Medical Microclave Connectors in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501828 and owned by ICU Medical Inc.. The device was registered on July 02, 2018.

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
DE0501828
ICU Medical Microclave Connectors
HSA Registration Number: DE0501828
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Product Description

As an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery. A small, sterile, stand-alone, needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position, and through which IV access is gained via blunt cannula separation of a septum. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0501828
Registration Date
July 02, 2018
Change Notification Approval Date
June 09, 2022
Retention Due Date
July 01, 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)
22 cm (8.5") Smallbone Pressure Infusion (400psig) Ext Set w/2 Microclaveยฎ Clear, Y-Connector, Clamp, Rotating Luer 15 cm (6") Appx 0.22ml, Smallbone Pressure Infusion (400psig) Ext Set w/Micorclaveยฎ Clear, Clamp, Rotating Luer
Model Identifier(s)
011-MC330253 011-MC330254