Eversense E3 Smart Transmitter Kit FG-5900-01-001

GUDID 00817491022912

Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.

SENSEONICS, INCORPORATED

Implantable glucose monitoring system transmitter

• Primary Device ID: 00817491022912
• NIH Device Record Key: 4c8a5e0d-632d-49ce-9ae6-712d145ec2cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eversense E3 Smart Transmitter Kit
• Version Model Number: FG-5900-01-001
• Catalog Number: FG-5900-01-001
• 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: false
• Single Use: true
• Lot Batch: true
• 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
• 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 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817491022912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160048

FDA Product Code

• QHJ: Sensor, Glucose, Implanted, Non-Adjunctive Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-18
• Device Publish Date: 2022-03-10

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