Brio Device, LLC 220498

GUDID 00857595005787

Thumb-controlled Articulating Intubation Stylet - 4cm x 5mm articulation segment

SUMMIT MEDICAL PRODUCTS, INC.

Endotracheal tube introducer, single-use

• Primary Device ID: 00857595005787
• NIH Device Record Key: 4f87e077-0d5e-4bb3-a67d-bed5aafb1b76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brio Device, LLC
• Version Model Number: 220498
• Catalog Number: 220498
• Company DUNS: 831704841
• Company Name: SUMMIT MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: (801) 352-1888
• Email: service@ambitpump.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857595005787 [Primary]
GS1	20857595005781 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• BSR: Stylet, Tracheal Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-07
• Device Publish Date: 2018-12-06

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