RESPONDER 5, STANDARD,NO ENTERTAINMENT 19210

GUDID 00840828143745

RESPONDER 5, STANDARD,NO ENTERTAINMENT

CURBELL MEDICAL PRODUCTS, INC.

Pillow speaker

• Primary Device ID: 00840828143745
• NIH Device Record Key: 25590a7b-9731-4752-80cd-a509469ad8d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESPONDER 5, STANDARD,NO ENTERTAINMENT
• Version Model Number: 4D411U-201000F
• Catalog Number: 19210
• 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: false
• 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: 1-800-235-7500
• Email: mwinter@curbell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840828143745 [Primary]

FDA Product Code

• IQA: System, Environmental Control, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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• 00840828194105: 4D41EN-968412A
• 00840828194082: 4D41EN-975412A