FDA UDI
In Commercial Distribution
🇺🇸 United States
FreeStyle Libre 2 Plus
DI: 00357599836016
·
Model: 78749
·
ABBOTT DIABETES CARE INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FreeStyle Libre 2 Plus
- Primary DI
- 00357599836016
- Version / Model
- 78749
- Catalog Number
- 78749
- Company Name
- ABBOTT DIABETES CARE INC
- Labeler DUNS
- 966390890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-25
- Public Version
- 2
- Public Version Date
- 2026-01-05
- Public Version Status
- Update
- Public Device Record Key
- 36bdff4f-2967-4ab4-b83c-d5df6b03b67a
Device Description
FreeStyle Libre 2 Plus Sensor Not For Retail Sale
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| QBJ | Integrated Continuous Glucose Monitoring system, factory calibrated | Clinical Chemistry | 862.1355 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44611 | Percutaneous interstitial fluid glucose monitoring system, electrochemical | An assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or 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 may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30357599836017 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00357599836016 | GS1 |
Customer Contacts
- Phone
- +1(855)632-8658
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 82 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal