PRiO-mini 84 Location Keyguard

GUDID 00858526006682

This keyguard specifically designed to work with 84 LAMP WFL vocabulary files on the PRiO-mini.

PRENTKE ROMICH COMPANY

Voice synthesizer/digitizer

• Primary Device ID: 00858526006682
• NIH Device Record Key: 82d46789-89a7-4a74-b74a-c198b524d594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRiO-mini 84 Location Keyguard
• Version Model Number: 17656
• Company DUNS: 080143399
• Company Name: PRENTKE ROMICH COMPANY
• 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: false
• Lot Batch: false
• Serial Number: false
• 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: true

Customer Support Contacts

• Phone: 800-262-1984
• Email: info@prentrom.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858526006682 [Primary]

FDA Product Code

• ILQ: System, Communication, Powered

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: 2019-02-25
• Device Publish Date: 2019-01-25

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