Eversense® Pouch Containing Sensor and Holder N/A

GUDID 00817491021434

Eversense Pouch contains one Eversense Sensor in a Sensor holder.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system sensor

• Primary Device ID: 00817491021434
• NIH Device Record Key: c2b4d679-1f17-45c2-899a-6fe48a969b98
• Commercial Distribution Discontinuation: 2019-02-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Eversense® Pouch Containing Sensor and Holder
• Version Model Number: 102095-67A
• Catalog Number: N/A
• 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	00817491021434 [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® Pouch Containing Sensor and Holder]

• 00817491021434: Eversense Pouch contains one Eversense Sensor in a Sensor holder.
• 00817491022363: Eversense Pouch contains one Eversense Sensor in a Sensor holder.