GEN4 PLUS, DIRECT ACCESS 23833

GUDID 00840828166812

GEN4 PLUS, DIRECT ACCESS

CURBELL MEDICAL PRODUCTS, INC.

Pillow speaker

• Primary Device ID: 00840828166812
• NIH Device Record Key: cdadd0f9-bac4-4ef9-9ca8-ab5d52e25d5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEN4 PLUS, DIRECT ACCESS
• Version Model Number: 5C190U-Z00700398
• Catalog Number: 23833
• Company DUNS: 796452311
• Company Name: CURBELL 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18002357500
• Email: mwinter@curbell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840828166812 [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: 2019-04-04
• Device Publish Date: 2019-03-27

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