SMART BAG MO 01BM3211-MO-TL-CS

GUDID 17540195000497

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 ID: 17540195000497
• NIH Device Record Key: 4373fb1e-0f92-4214-9af7-3000b211bf14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMART BAG MO
• Version Model Number: 01BM3211-MO-TL
• Catalog Number: 01BM3211-MO-TL-CS
• Company DUNS: 206449154
• Company Name: O-Two Medical Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-387-3405
• Email: cs@otwo.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195000490 [Primary]
GS1	17540195000497 [Package]; Contains: 07540195000490; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021328

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-10
• Device Publish Date: 2019-05-02

On-Brand Devices [SMART BAG MO]

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