Eversense® Charging Accessories Pack FG-6000-01-301

GUDID 00817491021908

Eversense® Charging Accessories Pack contains the Charging Cradle, US Configuration Power Supply and a USB Cable.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system

• Primary Device ID: 00817491021908
• NIH Device Record Key: 682a665d-11e4-4011-b74c-a0a3ac8a7ff0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eversense® Charging Accessories Pack
• Version Model Number: FG-6000-01-301
• Catalog Number: FG-6000-01-301
• Company DUNS: 966865636
• Company Name: SENSEONICS, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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: false

Customer Support Contacts

• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491021908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160048

FDA Product Code

• QCD: Continuous Glucose Monitor, Implanted, Adjunctive Use

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: 2019-11-27
• Device Publish Date: 2018-10-09

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