SMART BAG MO - The SMART BAG MO Manual Resuscitator is Bag Valve - O-Two Medical Technologies Inc

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 resuscitator.

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More Product Details

Catalog Number

01BM3200-MO-TL-CS

Brand Name

SMART BAG MO

Version/Model Number

01BM3200-MO-TL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Device Record Status

Public Device Record Key

21b42276-ff56-47b3-8cd1-a4ec0a27a88d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

17540195000206

Quantity per Package

12

Contains DI Package

07540195000209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated carton

"O-TWO MEDICAL TECHNOLOGIES INC" Characteristics
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