SMART BAG MO

Primary DI
07540195000483
Brand
SMART BAG MO
Company
O-Two Medical Technologies Inc
Model
01BM3211-MOTP
Catalog number
01BM3211-MOTP-CS
Device description
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.
Published
2019-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTMVentilator, Emergency, Manual (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021328000SMART BAG MOO-Two Systems International, Inc.2003-06-26BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540195000480PackageGS112In Commercial Distribution
07540195000483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754019500048017540195000480
07540195000483075401950004837540195000483

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-387-3405cs@otwo.com

Regulatory Flags#

DUNS number
206449154
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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07540195005174O-Two01CV801501CV8015-CS2019-05-31
07540195005181O-Two01CV801601CV8016-CS2019-05-31
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