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Smith Medical Bivona® Mid-Range Aire-Cuf® Adjustable Neck Flange Hyperflex™ Tracheostomy Tube - HSA Registration DE0016007

Access comprehensive regulatory information for Smith Medical Bivona® Mid-Range Aire-Cuf® Adjustable Neck Flange Hyperflex™ Tracheostomy Tube in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016007 and owned by Smiths Medical ASD, Inc.. The device was registered on July 18, 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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CLASS C
DE0016007
Smith Medical Bivona® Mid-Range Aire-Cuf® Adjustable Neck Flange Hyperflex™ Tracheostomy Tube
HSA Registration Number: DE0016007
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Product Description

This device is not intended for long-term use. This tube provides temporary airway access for a tracheotomized patient when determining the optimal tube length for a patient. This tube must be replaced with a fixed neck flange tracheostomy tube when the optimal length is determined.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDC00110
HS Code
90183990
Registration Information
Registration Number
DE0016007
Registration Date
July 18, 2014
Change Notification Approval Date
June 16, 2020
Retention Due Date
July 17, 2025
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 HYPERFLEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE MID RANGE AIRE-CUF ADULT HYPERFLEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE MID RANGE AIRE-CUF ADULT HYPERFLEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE MID RANGE AIRE-CUF ADULT HYPERFLEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE MID RANGE AIRE-CUF
Model Identifier(s)
75HA60 75HA70 75HA80 75HA90