SMART BAG MO 01`BM3211-MO-CS

GUDID 17540195000145

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 suppl

O-Two Medical Technologies Inc

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 17540195000145
• NIH Device Record Key: b5776e40-404f-4257-a9bd-85e2117f8c1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMART BAG MO
• Version Model Number: 01BM3211-MO
• Catalog Number: 01`BM3211-MO-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	07540195000148 [Primary]
GS1	17540195000145 [Package]; Contains: 07540195000148; Package: Corrugated carton [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-23

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