Samrt BAG MO

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…

Registry build 21.09.26

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.

8manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Fujian (4), Zhejiang (1), Guangdong (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BTM
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
VR Medical Technology Co., Ltd. Kunshan Jiangsu Contract manufacturer 13
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Laerdal Medical (Suzhou) Co., Ltd. 215009 Suzhou Jiangsu Province Repacker / relabeller 12
Xiamen Compower Medical Tech. Co., Ltd. Xiamen Fujian Contract manufacturer 9

Record

Regulatory record for Samrt BAG MO
Listed by O-TWO Medical Technologies, Inc., Canada
FDA product code BTM
Device type Ventilator, Emergency, Manual (Resuscitator)
Device class Class 2
Regulation 21 CFR 868.5915
Establishment Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k) K021328
Record published 2015-10-23
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date, serial number
Storage Storage environment temperature -40 to 60 °C

Catalogue Numbers

Catalogue numbers for Samrt BAG MO
Catalogue number Size Status
01BM3110-MO In distribution
01BM3400-MO In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ventlab Ventlab, LLC 405
CPR-2 Bag Mercury Medical Enterprises, LLC 231
CPR Bag Mercury Medical Enterprises, LLC 187
Vital Signs™ Airlife, Inc. 102
Medline Medline Industries, Inc. 78
Spur® II Pediatric ResuscitatorSingle Patient Use Resuscitator Ambu A/S 74
Spur® II Adult ResuscitatorSingle Patient Use Resuscitator Ambu A/S 66
Hudson RCI Teleflex Medical LLC 56
Medline Industries, Inc. Medline Industries, Inc. 53
Portex ICU Medical, Inc 45
Spur® II Infant ResuscitatorSingle Patient Use Resuscitator Ambu A/S 45
Curaplex® Bound Tree Medical, LLC 38

Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer