Duns Number:206449154
Device Description: The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self infl 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 Adult patient. For SMART BAG MO, the flow limiting valve can be disabled to permit conventional operation of the resuscitatorThe Child resuscitator comes standard with a Pressure Relief Valve set at 40 cm H2O which can be overridden by the operator. A pressure relief system, set at either 40 cm H2O or 60 cm H2O, is available for the Adult resuscitator. When used with a supplemental oxygen supply, the device may provide 100% oxygen on every squeeze of the bag.For SMART BAG MO, the flow limiting valve can be disabled to permit conventional operation of the resuscitator.
Catalog Number
01BM3200-MO-CS
Brand Name
SMART BAG MO
Version/Model Number
01BM3200-MO
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K021328,K021328
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
0e72e6bd-bcea-480f-a240-bf9e37236bc7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 23, 2015
Package DI Number
17540195000084
Quantity per Package
12
Contains DI Package
07540195000087
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
corrugated carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |