Burn Navigator 1143

GUDID B2551143

Burn Navigator RX

ARCOS, INC.

Clinical information system web-based application software

• Primary Device ID: B2551143
• NIH Device Record Key: e44b061a-84a1-46a5-9e58-0d83dddede0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burn Navigator
• Version Model Number: RX
• Catalog Number: 1143
• Company DUNS: 831782672
• Company Name: ARCOS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: 877-542-8025
• Email: support@arcosmedical.com
• Phone: 877-542-8025
• Email: support@arcosmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2551143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121659

FDA Product Code

• PDT: Burn Resuscitation Decision Support Software

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-14

On-Brand Devices [Burn Navigator]

• B2551143: Burn Navigator RX
• B2551125: Burn Navigator H2 Transport
• B2551120: Burn Navigator H2 model