FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TRUEtrack
DI: 00021292009281
·
Model: TRUEtrack Blood Glucose Meter - Free Meter Only
·
TRIVIDIA HEALTH, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- TRUEtrack
- Primary DI
- 00021292009281
- Version / Model
- TRUEtrack Blood Glucose Meter - Free Meter Only
- Catalog Number
- A4088-85
- Company Name
- TRIVIDIA HEALTH, INC.
- Labeler DUNS
- 151810868
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-28
- Public Version
- 3
- Public Version Date
- 2021-11-01
- Public Version Status
- Update
- Public Device Record Key
- e3724546-01e1-429d-a6f0-9a0f1e5059bb
- Distribution End Date
- 2017-11-06
Device Description
HealthWise Pharmacy TRUEtrack Blood Glucose Meter - Free Meter Only
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
| 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 | 10021292009288 | GS1 | CASE | 4 | Not in Commercial Distribution | 2017-11-06 |
| Primary | 00021292009281 | GS1 |
Customer Contacts
- Phone
- +1(800)803-6025
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032657 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 30 – 86 Degrees Fahrenheit