FDA UDI
In Commercial Distribution
🇺🇸 United States
Eversense® Charging Accessories Pack
DI: 00817491021908
·
Model: FG-6000-01-301
·
SENSEONICS, INCORPORATED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Eversense® Charging Accessories Pack
- Primary DI
- 00817491021908
- Version / Model
- FG-6000-01-301
- Catalog Number
- FG-6000-01-301
- Company Name
- SENSEONICS, INCORPORATED
- Labeler DUNS
- 966865636
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-09
- Public Version
- 3
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- 682a665d-11e4-4011-b74c-a0a3ac8a7ff0
Device Description
Eversense® Charging Accessories Pack contains the Charging Cradle, US Configuration Power Supply and a USB Cable.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QCD | Continuous Glucose Monitor, Implanted, Adjunctive Use | Unknown | 3 | |
| QHJ | Sensor, Glucose, Implanted, Non-Adjunctive Use | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61915 | Implantable glucose monitoring system | An assembly of portable, battery-powered devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It typically consists of a sterile, subcutaneously-implanted sensor with dedicated implantation devices (e.g., blunt dissector, introducer needle), and an externally worn transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817491021908 | GS1 |
Customer Contacts
- Phone
- 844-736-7348
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160048 | 000 |