Identity
- Trade Name
- Eversense 365 Smart Transmitter Kit (Retail) FDA UDI
- Generic Name
- Implantable glucose monitoring system transmitter FDA UDI
- Device Name
- Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card. FDA UDI
- Model / Reference
- FG-4001-01-001 FDA UDI
- Description
- Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card. FDA UDI
Identifiers
- Catalog Number
- FG-4001-01-001 FDA UDI
- Primary DI / UDI-DI
- 00817491024244 FDA UDI
- 510(k) Number
- K241335 FDA UDI
- FDA Product Code
- SBA FDA UDI
- GMDN Term
- Implantable glucose monitoring system transmitter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1357 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Implantable glucose monitoring system transmitter
Eversense 365 Smart Transmitter Kit (Retail) by Senseonics, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable glucose monitoring system transmitter.
- Eversense E3 Smart Transmitter Kit - Provider Purchase — SENSEONICS, INCORPORATED · Class III
- Eversense 365 Smart Transmitter Kit (DME) — SENSEONICS, INCORPORATED · Class II
- Eversense E3 Smart Transmitter Kit - Retail — SENSEONICS, INCORPORATED · Class III
- Eversense E3 Smart Transmitter Kit — SENSEONICS, INCORPORATED · Class III
- Eversense Charging Cable — SENSEONICS, INCORPORATED · Class III
- Eversense Power Adapter — SENSEONICS, INCORPORATED · Class III
- Eversense 365 Smart Transmitter Kit (Provider Purchase) — SENSEONICS, INCORPORATED · Class II
Cleared under the same submission
K241335 also covers:
- Eversense 365 Adhesive Patches Kit — SENSEONICS, INCORPORATED
- Eversense 365 Mobile Application (Android) — SENSEONICS, INCORPORATED
- Eversense 365 Mobile Application (iOS) — SENSEONICS, INCORPORATED
- Eversense 365 Sensor Kit (DME) — SENSEONICS, INCORPORATED
- Eversense 365 Sensor Kit (Provider Purchase) — SENSEONICS, INCORPORATED
- Eversense 365 Sensor Kit (Retail) — SENSEONICS, INCORPORATED
- Eversense 365 Smart Transmitter Kit (DME) — SENSEONICS, INCORPORATED
- Eversense 365 Smart Transmitter Kit (Provider Purchase) — SENSEONICS, INCORPORATED
- Pouch Containing Grafted Sensor and Holder, Eversense 365 — SENSEONICS, INCORPORATED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Senseonics, Incorporated
Sources (1)
- FDA UDI 745ea9b0-2677-4001-8374-01a8cbb6705c 37 fields · synced May 30, 2026