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, single-use 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 Aduit patient. For SMART BAG MO, the flow limiting valve can be disabled to permit conventional operation of the resuscitator. FDA UDI
Model / Reference: 01BM3211-MO-TL 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 Aduit patient. For SMART BAG MO, the flow limiting valve can be disabled to permit conventional operation of the resuscitator. FDA UDI

Identifiers

Catalog Number: 01BM3211-MO-TL-CS FDA UDI
Primary DI / UDI-DI: 07540195000490 FDA UDI
510(k) Number: K021328 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Pulmonary resuscitator, manual, single-use 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulmonary resuscitator, manual, single-use

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, single-use.

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Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
VT Sure — Pulmodyne Inc. · Class II
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
Ventlab — Ventlab Corp. · Class I
Ventlab — Ventlab Corp. · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: O-Two Medical Technologies Inc

Sources (1)

FDA UDI 4373fb1e-0f92-4214-9af7-3000b211bf14 37 fields · synced May 31, 2026