FDA UDI
In Commercial Distribution
🇺🇸 United States
CONTOUR® NEXT
DI: 10301937278706
·
Model: 7278
·
ASCENSIA DIABETES CARE US INC.
Product Codes
4
GMDN Terms
1
Identifiers
4
Pkg Device Count
35
Basic Information
- Brand Name
- CONTOUR® NEXT
- Primary DI
- 10301937278706
- Version / Model
- 7278
- Catalog Number
- 7278
- Company Name
- ASCENSIA DIABETES CARE US INC.
- Labeler DUNS
- 080028910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 35
- Record Status
- Published
- Publish Date
- 2017-11-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 10a8c694-48db-4d58-b837-910520d11ed4
Device Description
Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
| OZP | Artificial Pancreas Device System, Single Hormonal Control | Unknown | 3 | |
| OZO | Artificial Pancreas Device System, Threshold Suspend | 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 |
|---|---|---|---|---|---|---|
| Package | 40301937278707 | GS1 | case | 12 | In Commercial Distribution | |
| Package | 00301937278709 | GS1 | carton | 2 | In Commercial Distribution | |
| Primary | 10301937278706 | GS1 | ||||
| Unit of Use | 00301937278013 | GS1 |
Customer Contacts
- Phone
- 800-348-8100
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store test strips in their original bottle only. Always close the lid immediately and tightly after removing a test strip. Do not use after expiration date.
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit