FDA UDI
In Commercial Distribution
🇺🇸 United States
CONTOUR® NEXT LINK 2.4
DI: 00301936260019
·
Model: 6260
·
ASCENSIA DIABETES CARE US INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CONTOUR® NEXT LINK 2.4
- Primary DI
- 00301936260019
- Version / Model
- 6260
- Catalog Number
- 6260
- Company Name
- ASCENSIA DIABETES CARE US INC.
- Labeler DUNS
- 080028910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-25
- Public Version
- 5
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- c3a40fde-1fa5-4b4e-a9c0-908ced8e77d1
Device Description
Wireless Blood Glucose Monitoring System. 1 Kit. For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OZO | Artificial Pancreas Device System, Threshold Suspend | Unknown | 3 | |
| OZP | Artificial Pancreas Device System, Single Hormonal Control | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62537 | Glucose monitoring system IVD, home-use | A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00301936260019 | GS1 |
Customer Contacts
- Phone
- 18003488100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150001 | 000 |
| P160017 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 48 – 86 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity