FDA UDI
In Commercial Distribution
🇺🇸 United States
CONTOUR®
DI: 10301937110013
·
Model: 7110B
·
ASCENSIA DIABETES CARE US INC.
Product Codes
2
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- CONTOUR®
- Primary DI
- 10301937110013
- Version / Model
- 7110B
- Catalog Number
- 7110B
- 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
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2018-12-03
- Public Version Status
- Update
- Public Device Record Key
- 6cd1987a-6492-4945-9f3b-efc78c34a192
Device Description
Control Solution - Low, 1 x 2.5 mL
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41819 | Glucose IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50301937110011 | GS1 | out.shipper/lg case | 32 | In Commercial Distribution | |
| Package | 40301937110014 | GS1 | in. shipper/sm. case | 12 | In Commercial Distribution | |
| Package | 00301937110016 | GS1 | carton | 1 | In Commercial Distribution | |
| Primary | 10301937110013 | GS1 | ||||
| Secondary | 0193-7110-01 | NDC/NHRIC |
Customer Contacts
- Phone
- 18003488100
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight. Do not use after expiration date.
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit