FDA UDI
In Commercial Distribution
🇺🇸 United States
CONTOUR®NEXT
DI: 10301937550154
·
Model: 7550
·
ASCENSIA DIABETES CARE US INC.
Product Codes
3
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- CONTOUR®NEXT
- Primary DI
- 10301937550154
- Version / Model
- 7550
- Catalog Number
- 7550
- 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
- 2019-08-30
- Public Version
- 2
- Public Version Date
- 2019-11-22
- Public Version Status
- Update
- Public Device Record Key
- c1943aef-2a71-4eb5-a589-890a2ab034de
Device Description
Blood glucose test strips. Sold in a carton of 15 test strips.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| OZP | Automated Insulin Dosing Device System, Single Hormonal Control | Unknown | 3 | |
| OZO | Automated Insulin Dosing , Threshold Suspend | Unknown | 3 | |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
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 | 40301937550155 | GS1 | shipper/case | 24 | In Commercial Distribution | |
| Package | 00301937550157 | GS1 | carton | 15 | In Commercial Distribution | |
| Primary | 10301937550154 | GS1 | ||||
| Package | 00301937550065 | GS1 | shelf organizer | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-348-8100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191286 | 000 |
| P150001 | 066 |
| P160017 | 062 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 48 – 86 Degrees Fahrenheit