DEVICE: SMART BAG MO (07540195000124)
Device Identifier (DI) Information
SMART BAG MO
01BM3210-MO
In Commercial Distribution
01BM3210-MO
O-Two Medical Technologies Inc
01BM3210-MO
In Commercial Distribution
01BM3210-MO
O-Two Medical Technologies Inc
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.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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36086 | Pulmonary resuscitator, manual, single-use |
A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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BTL | Ventilator, Emergency, Powered (Resuscitator) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K021328 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -18 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e7032d97-2979-480e-8b2f-9505c222bbed
July 06, 2018
3
October 23, 2015
July 06, 2018
3
October 23, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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17540195000121 | 12 | 07540195000124 | In Commercial Distribution | corrugated carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-387-3405
cs@otwo.com
cs@otwo.com