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Smiths Medical Bivonaยฎ Cuffless Adult Tracheostomy Tubes - HSA Registration DE0017912

Access comprehensive regulatory information for Smiths Medical Bivonaยฎ Cuffless Adult Tracheostomy Tubes in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0017912 and owned by Smiths Medical ASD, Inc.. The device was registered on March 01, 2016.

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
DE0017912
Smiths Medical Bivonaยฎ Cuffless Adult Tracheostomy Tubes
HSA Registration Number: DE0017912
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Product Description

This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient reuse.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDC00102
HS Code
90183990
Registration Information
Registration Number
DE0017912
Registration Date
March 01, 2016
Change Notification Approval Date
October 22, 2020
Retention Due Date
February 28, 2026
Product Owner
Short Name
Smiths Medical ASD, Inc.
Address
6000 Nathan Lane North, Minneapolis MN 55442, UNITED STATES
Registrant
Address
1 KALLANG JUNCTION, Vanguard Campus, #05-01, SINGAPORE 339263
Importer
Address
1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model Information
Model Name(s)
Adult Tracheostomy Tube, Cuffless Adult Tracheostomy Tube, Cuffless Adult Tracheostomy Tube, Cuffless Adult Tracheostomy Tube, Cuffless Adult Tracheostomy Tube, Cuffless
Model Identifier(s)
60A150 60A160 60A170 60A180 60A190