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Smart Bag Mo

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name
SMART BAG MO FDA UDI
Generic Name
Pulmonary resuscitator, manual, reusable FDA UDI
Device Name
The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating bag, a one way valve and a face mask designed to supply accurate controlled ventilation to a non-breathing patient by the compression of the bag portion of the device by the operator. Similar in all respects to the conventional BVMs, 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. It is designed for use in various clinical settings to provide respiratory support to the respiratory distressed or non-breathing Child patient. For SMART BAG MO, the flow limiting valve can be disabled to permit conventional operation of the resuscitator. The Child resuscitator comes standard with a Pressure Relief Valve set at 40 cm H2O which can be overridden by the operator. FDA UDI
Model / Reference
01BM3410-MO FDA UDI
Description
The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating bag, a one way valve and a face mask designed to supply accurate controlled ventilation to a non-breathing patient by the compression of the bag portion of the device by the operator. Similar in all respects to the conventional BVMs, 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. It is designed for use in various clinical settings to provide respiratory support to the respiratory distressed or non-breathing Child patient. For SMART BAG MO, the flow limiting valve can be disabled to permit conventional operation of the resuscitator. The Child resuscitator comes standard with a Pressure Relief Valve set at 40 cm H2O which can be overridden by the operator. FDA UDI

Identifiers

Catalog Number
01BM3410-MO FDA UDI
Primary DI / UDI-DI
07540195000186 FDA UDI
510(k) Number
K021328 FDA UDI
FDA Product Code
BTM FDA UDI
GMDN Term
Pulmonary resuscitator, manual, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5915 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pulmonary resuscitator, manual, reusable

Smart Bag Mo by O-Two Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary resuscitator, manual, reusable.

Cleared under the same submission

K021328 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
O-Two Medical Technologies Inc

Sources (1)

  • FDA UDI 75b01f10-f8a0-461e-9a72-3eeb93b1a3a4 37 fields · synced Jun 8, 2026