FDA UDI
In Commercial Distribution
🇺🇸 United States
Pouch Containing Grafted Sensor and Holder, Eversense 365
DI: 00817491024220
·
Model: 102606-023
·
SENSEONICS, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pouch Containing Grafted Sensor and Holder, Eversense 365
- Primary DI
- 00817491024220
- Version / Model
- 102606-023
- 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
- 3ed9a38e-e30a-44ab-8294-6b9382ce57f2
Device Description
Pouch contains one Eversense 365 Sensor in a Sensor holder.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 61930 | Implantable glucose monitoring system sensor | A sterile device intended to be implanted subcutaneously for continuous monitoring of glucose levels in interstitial fluid, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is a small, rod-shaped sensor consisting of an electrochemical or optical glucose detector that emits signals which are sent to an externally-worn transmitter (not included) via a wireless connection. It is passively-powered by the transmitter. Dedicated implantation devices (e.g., blunt dissector, cannula) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817491024220 | 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
- 36 – 46 Degrees Fahrenheit