Eversense® Sensor Kit FG-4200-00-301

GUDID 00817491022349

Eversense Sensor Kit contains one Eversense Sensor.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system sensor

• Primary Device ID: 00817491022349
• NIH Device Record Key: 5c61ca67-601d-4c38-9104-ff43691e5ca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eversense® Sensor Kit
• Version Model Number: FG-4200-00-301
• Catalog Number: FG-4200-00-301
• Company DUNS: 966865636
• Company Name: SENSEONICS, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com
• Phone: 844-736-7348
• Email: support@eversensediabetes.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491022349 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-02-06

On-Brand Devices [Eversense® Sensor Kit]

• 00817491021410: Eversense Sensor Kit contains one Eversense Sensor.
• 00817491022349: Eversense Sensor Kit contains one Eversense Sensor.