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O-Two SMART BAG® MO Disposable Bag Valve Mask Resuscitator - HSA Registration DE0500374

Access comprehensive regulatory information for O-Two SMART BAG® MO Disposable Bag Valve Mask Resuscitator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500374 and owned by O-Two Medical Technologies Inc. The device was registered on December 16, 2015.

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
DE0500374
O-Two SMART BAG® MO Disposable Bag Valve Mask Resuscitator
HSA Registration Number: DE0500374
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Product Description

The SMART BAG® MO Disposable Bag Valve Mask resuscitator is a single use device for manual ventilation. The SMART BAG MO offers accurate controlled ventilation that significantly reduces the risk of gastric insufflation. The patient’s airway pressure is maintained at an optimally low level due to the SMART® technology in the bag that responds to both the rescuer’s squeeze of the bag and the patient’s own respiratory condition. The Child resuscitator comes standard with a Pressure Relief Valve set at 40 cm H2O which can be overridden by the operator. When used with a supplemental oxygen supply, the device may provide 100% oxygen on every squeeze of the bag

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HS Code
90192000
Registration Information
Registration Number
DE0500374
Registration Date
December 16, 2015
Retention Due Date
December 15, 2025
Product Owner
Short Name
O-Two Medical Technologies Inc
Address
7575 Kimbel Street, Unit 5, Mississauga, Ontario, Canada L5S 1C8, CANADA
Registrant
Address
1090 LOWER DELTA ROAD, #05-15/16, SINGAPORE 169201
Importer
Address
1090 LOWER DELTA ROAD, #05-15/16, SINGAPORE 169201
Model Information
Model Name(s)
SMART BAG MO Disposable Adult Bag Valve Mask Resuscitator SMART BAG MO Disposable Child Bag Valve Mask Resuscitator
Model Identifier(s)
01BM3201-MO-Cs 01BM3211-MO-Cs