SMART BAG MO 01BM3201-MOTP-CS

GUDID 17540195000237

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.

O-Two Medical Technologies Inc

Pulmonary resuscitator, manual, single-use
Primary Device ID17540195000237
NIH Device Record Key74566715-66e4-4501-88a8-0b5908c3f656
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMART BAG MO
Version Model Number01BM3201-MOTP
Catalog Number01BM3201-MOTP-CS
Company DUNS206449154
Company NameO-Two Medical Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-387-3405
Emailcs@otwo.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195000230 [Primary]
GS117540195000237 [Package]
Contains: 07540195000230
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-10
Device Publish Date2019-05-02

On-Brand Devices [SMART BAG MO]

17540195000220The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000206The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
07540195000186The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000145The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
07540195000124The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000107The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000084The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
07540195000025The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000497The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000480The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating
17540195000237The SMART BAG MO Manual Resuscitator is Bag Valve Mask Resuscitator comprising a self inflating

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