Identity
- Trade Name
- Eversense® Smart Transmsitter Kit - Retail FDA UDI
- Generic Name
- Implantable glucose monitoring system transmitter FDA UDI
- Device Name
- Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card. FDA UDI
- Model / Reference
- FG-3301-01-001 FDA UDI
- Description
- Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card. FDA UDI
Identifiers
- Catalog Number
- FG-3301-01-001 FDA UDI
- Primary DI / UDI-DI
- 00817491021458 FDA UDI
- PMA Number
- P160048 FDA UDI
- FDA Product Code
- QCD FDA UDIQHJ FDA UDI
- GMDN Term
- Implantable glucose monitoring system transmitter FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
Eversense® Smart Transmsitter Kit - Retail by Senseonics, Incorporated — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P160048 also covers:
- Eversense Adhesive Patches, 10-pack White — SENSEONICS, INCORPORATED
- Eversense Charging Cable — SENSEONICS, INCORPORATED
- Eversense E3 Adhesive Patches Kit, 180-pack — SENSEONICS, INCORPORATED
- Eversense E3 Insertion Tools Kit — SENSEONICS, INCORPORATED
- Eversense E3 Pouch Containing Sensor and Holder — SENSEONICS, INCORPORATED
- Eversense E3 Sensor Kit - DME — SENSEONICS, INCORPORATED
- Eversense E3 Sensor Kit - Retail — SENSEONICS, INCORPORATED
- Eversense E3 Sensor Kit – Provider Purchase — SENSEONICS, INCORPORATED
- Eversense E3 Smart Transmitter Kit — SENSEONICS, INCORPORATED
- Eversense E3 Smart Transmitter Kit - Provider Purchase — SENSEONICS, INCORPORATED
- Eversense E3 Smart Transmitter Kit - Retail — SENSEONICS, INCORPORATED
- Eversense Insertion Tools Kit — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Senseonics, Incorporated
Sources (1)
- FDA UDI 95058c2d-df78-4fb8-9b14-e313f4fa055a 38 fields · synced May 31, 2026