FDA UDI
In Commercial Distribution
🇺🇸 United States
CONTOUR® PLUS BLUE
DI: 00301937036019
·
Model: 7036
·
ASCENSIA DIABETES CARE US INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CONTOUR® PLUS BLUE
- Primary DI
- 00301937036019
- Version / Model
- 7036
- Catalog Number
- 90008381
- 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
- 2024-08-01
- Public Version
- 4
- Public Version Date
- 2025-04-01
- Public Version Status
- Update
- Public Device Record Key
- 0ac1fe3b-7308-4a0e-a31e-168a99ca3a84
Device Description
"Contour Plus Blue Blood Glucose monitoring System For Self- testing, mornitoring and management of blood glucose. Kit Contains: -Contour Plus Blue blood glucose meter (product of Indonesia) -Micolet Next Lancing device (Product of Poland) -User Guide -Quick Reference Guide - Carrying Case (Product of China) Control solutions are required but not included and must be purchased separately"
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 40301937036017 | GS1 | shipper/case | 4 | In Commercial Distribution | |
| Primary | 00301937036019 | GS1 |
Customer Contacts
- Phone
- 800-348-8100
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity