FDA UDI
In Commercial Distribution
🇺🇸 United States
Eversense 365 Smart Transmitter Kit (Provider Purchase)
DI: 00817491024251
·
Model: FG-4002-01-001
·
SENSEONICS, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Eversense 365 Smart Transmitter Kit (Provider Purchase)
- Primary DI
- 00817491024251
- Version / Model
- FG-4002-01-001
- Catalog Number
- FG-4002-01-001
- Company Name
- SENSEONICS, INCORPORATED
- Labeler DUNS
- 966865636
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-23
- Public Version
- 1
- Public Version Date
- 2024-10-01
- Public Version Status
- New
- Public Device Record Key
- 9aca8751-4ba7-4045-87b7-96e6e3a4bbc9
Device Description
Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SBA | Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate | Clinical Chemistry | 862.1357 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61912 | Implantable glucose monitoring system transmitter | A body-worn, battery-powered component of an implantable glucose monitoring system designed to wirelessly transmit glucose measurements continuously from the implanted sensor to a receiver (e.g., a mobile device). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817491024251 | GS1 |
Customer Contacts
- Phone
- 844-736-7348
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241335 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 95 Degrees Fahrenheit