FDA UDI
In Commercial Distribution
🇺🇸 United States
TRUE METRIX
DI: 00021292007836
·
Model: TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 50 Test Strips
·
TRIVIDIA HEALTH, INC.
Product Codes
2
GMDN Terms
1
Identifiers
132
Pkg Device Count
50
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Basic Information
- Brand Name
- TRUE METRIX
- Primary DI
- 00021292007836
- Version / Model
- TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 50 Test Strips
- Company Name
- TRIVIDIA HEALTH, INC.
- Labeler DUNS
- 151810868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 18
- Public Version Date
- 2025-11-03
- Public Version Status
- Update
- Public Device Record Key
- 7e872fe4-0311-4847-a9e3-5aded2059e57
Device Description
TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 50 Test Strips
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00021292007836 | GS1 | ||||
| Unit of Use | 00021292007799 | GS1 | ||||
| Package | 00708820859142 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10708820859132 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00708820859135 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10021292007277 | GS1 | Case | 24 | Not in Commercial Distribution | 2019-11-18 |
| Package | 00021292007270 | GS1 | Box | 2 | Not in Commercial Distribution | 2019-11-18 |
| Package | 10021292007260 | GS1 | Case | 24 | Not in Commercial Distribution | 2019-11-18 |
| Package | 00011822531023 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10021292007178 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00021292007171 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10077890394097 | GS1 | Case | 24 | Not in Commercial Distribution | 2025-08-15 |
| Package | 00077890394090 | GS1 | Box | 2 | Not in Commercial Distribution | 2025-08-15 |
| Package | 10077890394103 | GS1 | Case | 24 | Not in Commercial Distribution | 2022-01-07 |
| Package | 00077890394106 | GS1 | Box | 1 | Not in Commercial Distribution | 2022-01-07 |
| Package | 10052569138547 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00052569138540 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10052569138530 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00052569138533 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10052569138561 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00021292007201 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10021292007208 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00021292006204 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10021292006201 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00021292006198 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10021292006195 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00021292006181 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10021292006188 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00021292006167 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10021292006164 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00052569138564 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10011822531020 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00011822555944 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10011822555941 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00010939723444 | GS1 | Box | 1 | Not in Commercial Distribution | 2024-08-28 |
| Package | 10010939723441 | GS1 | Case | 24 | Not in Commercial Distribution | 2024-08-28 |
| Package | 00010939720443 | GS1 | Box | 1 | Not in Commercial Distribution | 2024-08-28 |
| Package | 10010939720440 | GS1 | Case | 24 | Not in Commercial Distribution | 2024-08-28 |
| Package | 00010939721440 | GS1 | Box | 2 | Not in Commercial Distribution | 2024-08-29 |
| Package | 10010939721447 | GS1 | Case | 24 | Not in Commercial Distribution | 2024-08-29 |
| Package | 00041220001309 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10041220001306 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00041220001316 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10041220001313 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00021292007140 | GS1 | Box | 1 | Not in Commercial Distribution | 2018-01-25 |
| Package | 10021292007147 | GS1 | Case | 24 | Not in Commercial Distribution | 2018-01-25 |
| Package | 00021292007072 | GS1 | Box | 1 | Not in Commercial Distribution | 2018-01-25 |
| Package | 10021292007079 | GS1 | Case | 24 | Not in Commercial Distribution | 2018-01-25 |
| Package | 00021292007089 | GS1 | Box | 2 | Not in Commercial Distribution | 2018-01-25 |
| Package | 10021292007086 | GS1 | Case | 24 | Not in Commercial Distribution | 2018-01-25 |
| Package | 00093351018978 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10093351018975 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00093351018985 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10093351018982 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00021292007263 | GS1 | Box | 1 | Not in Commercial Distribution | 2019-11-18 |
| Package | 10311917173945 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00311917173948 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10311917166909 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00311917166902 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 50096295126612 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00096295126617 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 50096295126629 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00096295126624 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 50096295126636 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00096295126631 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10050428287979 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00050428287972 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10050428333195 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00050428333198 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10087701426268 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00087701426261 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10087701426275 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00087701426278 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10087701426534 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00087701426537 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10708820859149 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00041415071780 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10041415071787 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00041415070783 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10041415070780 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 20021292006208 | GS1 | 360 | In Commercial Distribution | ||
| Package | 20021292007205 | GS1 | Case | 360 | In Commercial Distribution | |
| Package | 00725439988957 | GS1 | Box | 1 | Not in Commercial Distribution | 2020-02-25 |
| Package | 10725439988954 | GS1 | Case | 24 | Not in Commercial Distribution | 2020-02-25 |
| Package | 00725439988964 | GS1 | Box | 2 | Not in Commercial Distribution | 2020-02-25 |
| Package | 10725439988961 | GS1 | Case | 12 | Not in Commercial Distribution | 2020-02-25 |
| Package | 00021292007492 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10021292007499 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 00021292008703 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 20021292008707 | GS1 | Case | 360 | In Commercial Distribution | |
| Package | 00021292007621 | GS1 | Box | 1 | Not in Commercial Distribution | 2017-07-31 |
| Package | 20021292007625 | GS1 | Case | 360 | Not in Commercial Distribution | 2017-07-31 |
| Package | 00021292008918 | GS1 | Box | 1 | Not in Commercial Distribution | 2019-05-01 |
| Package | 10021292008915 | GS1 | Case | 24 | Not in Commercial Distribution | 2019-05-01 |
| Package | 00050428315415 | GS1 | BOX | 2 | In Commercial Distribution | |
| Package | 10050428315412 | GS1 | CASE | 12 | In Commercial Distribution | |
| Package | 00050428322659 | GS1 | BOX | 1 | In Commercial Distribution | |
| Package | 10050428322656 | GS1 | CASE | 24 | In Commercial Distribution | |
| Package | 00036800234543 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10036800234540 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 00036800234550 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10036800234557 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00036800234536 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10036800234533 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00321130788652 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10321130788659 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 00321130788645 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10321130788642 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00041520147769 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10041520147766 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 00041520147752 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10041520147759 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00041260007330 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10041260007337 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 00041260007347 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10041260007344 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00021292014254 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10021292014251 | GS1 | Case | 12 | Not in Commercial Distribution | 2020-04-24 |
| Package | 00010939958761 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10010939958768 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00010939958716 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10010939958713 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 00010939958709 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10010939958706 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 00050428087398 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10050428087395 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 00311917055152 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10311917055159 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 00713733812009 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 10713733812006 | GS1 | Case | 12 | In Commercial Distribution | |
| Package | 00021292015374 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 10021292015371 | GS1 | Case | 24 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)803-6025
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 86 Degrees Fahrenheit