EXPRESSION

GUDID G549ULTRA0

Rcs Management Corp

Assistive speech generator

• Primary Device ID: G549ULTRA0
• NIH Device Record Key: ea4db715-74b6-4ab0-a819-2e3284ea4d27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPRESSION
• Version Model Number: ULTRA
• Company DUNS: 119066352
• Company Name: Rcs Management Corp
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G549ULTRA0 [Primary]

FDA Product Code

• ILQ: System, Communication, Powered

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: 2024-11-29
• Device Publish Date: 2024-11-21

On-Brand Devices [EXPRESSION]

• G549ULTRA0: ULTRA
• G549SUPREME0: SUPREME
• G549MINI0: MINI
• G549MICRO0: MICRO
• G549CLASSIC0: CLASSIC