Eversense® Sensor Kit - Retail FG-4201-00-301

GUDID 00817491021427

Eversense Sensor Kit contains one Eversense Sensor.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system sensor

• Primary Device ID: 00817491021427
• NIH Device Record Key: 1a3531ed-b221-4a52-81e5-237b6721c9d4
• Commercial Distribution Discontinuation: 2019-02-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Eversense® Sensor Kit - Retail
• Version Model Number: FG-4201-00-301
• Catalog Number: FG-4201-00-301
• Company DUNS: 966865636
• Company Name: SENSEONICS, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491021427 [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: 2019-02-08
• Device Publish Date: 2018-07-16

On-Brand Devices [Eversense® Sensor Kit - Retail]

• 00817491021427: Eversense Sensor Kit contains one Eversense Sensor.
• 00817491022356: Eversense Sensor Kit contains one Eversense Sensor.