FDA UDI
In Commercial Distribution
🇺🇸 United States
TRUE FOCUS
DI: 00021292008956
·
Model: TRUE FOCUS Self Monitoring Test Strip - 50ct
·
TRIVIDIA HEALTH, INC.
Product Codes
3
GMDN Terms
1
Identifiers
4
Pkg Device Count
50
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Basic Information
- Brand Name
- TRUE FOCUS
- Primary DI
- 00021292008956
- Version / Model
- TRUE FOCUS Self Monitoring Test Strip - 50ct
- Company Name
- TRIVIDIA HEALTH, INC.
- Labeler DUNS
- 151810868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-06-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 20358578-208f-4890-b60c-bc354f1d8f73
Device Description
TRUE FOCUS Self Monitoring Test Strip - 50ct
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 |
|---|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| 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 |
|---|---|---|---|---|
| 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 | 10311917188086 | GS1 | CASE | 24 | In Commercial Distribution | |
| Package | 00311917188089 | GS1 | BOX | 1 | In Commercial Distribution | |
| Primary | 00021292008956 | GS1 | ||||
| Unit of Use | 00021292007812 | GS1 |
Customer Contacts
- Phone
- +1(800) 803-6025
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131013 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit