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ICU Medical Microclave IV Extension sets - HSA Registration DE0507679

Access comprehensive regulatory information for ICU Medical Microclave IV Extension sets in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507679 and owned by ICU Medical Inc.. The device was registered on January 12, 2023.

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
DE0507679
ICU Medical Microclave IV Extension sets
HSA Registration Number: DE0507679
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Product Description

The IV Extension Set is a single use, sterile, non-pyrogenic device indicated for use with an intravascular administration set. The IV Extension Set provides access for the administration of fluids from a container to a patient’s vascular system via a suitable vascular access device.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0507679
Registration Date
January 12, 2023
Retention Due Date
January 11, 2026
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)
7" (18 cm) Appx 0.69 ml, Ext Set w/MicroClave™ Clear, Clamp, Rotating Luer 4" Smallbore Trifuse Ext Set w/3 MicroClave® Clear, 3 Clamps, Rotating Luer 15 cm (6") Appx 0.87ml, Bifuse Ext Set w/2 MicroClave™ Clear, 2 Clamps, Rotating Luer 14 cm (5.5") Smallbore Bifuse Ext Set w/2 MicroClave® Clear, 2 Check Valves, 2 Clamps, Rotating Luer 14 cm (5.5") Smallbore Trifuse Ext Set w/3 MicroClave® Clear, 3 Check Valves, 3 Clamps, Rotating Luer 18 cm (7") Ext Set w/2 MicroClave™ Clear, 4-Way Stopcock, Rotating Luer 15 cm (6") Appx 0.35 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Clamps, Rotating Luer 8 cm (3") Smallbore Bifuse Ext Set w/2 MicroClave® Clear, 2 Clamps, Rotating Luer 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave® Clear, Clamp, Luer Slip
Model Identifier(s)
011-MC2005 011-MC33029 011-MC33064 011-MC33128 011-MC33131 011-MC33149 011-MC3322 011-MC33565 011-MC3381