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ICU Medical Swabcap - HSA Registration DE0503148

Access comprehensive regulatory information for ICU Medical Swabcap in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503148 and owned by ICU Medical Inc.. The device was registered on May 27, 2019.

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 C
DE0503148
ICU Medical Swabcap
HSA Registration Number: DE0503148
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Product Description

SwabCap is intended for use on swabable needlefree connectors as a cover to protect the needlefree connectors from potential contamination. The SwabCap acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap will disinfect the connector five (5) minutes after application and maintains a disinfected connector surface for up to seven (7) days if not removed., Standalone Medical Mobile Application:

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0503148
Registration Date
May 27, 2019
Change Notification Approval Date
January 13, 2022
Retention Due Date
May 26, 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)
SwabPackPlusโ„ข Swabpackยฎ, 10 Ct., Bag Swabpackยฎ, 10 Ct., Bag Swabcapยฎ Swabcapยฎ Swabpackยฎ, 25-ct. Bag Swabpackยฎ, 25-ct. Bag
Model Identifier(s)
SCRC3-10-1600 SCXT3-10-2000 SCXT3-10-2000G SCXT3-2000 SCXT3-2000G SCXT3-2400 SCXT3-2400G