FDA UDI
In Commercial Distribution
🇺🇸 United States
TRUEcontrol
DI: 00021292008376
·
Model: TRUEcontrol Solution Level 2
·
TRIVIDIA HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TRUEcontrol
- Primary DI
- 00021292008376
- Version / Model
- TRUEcontrol Solution Level 2
- Company Name
- TRIVIDIA HEALTH, INC.
- Labeler DUNS
- 151810868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-29
- Public Version
- 2
- Public Version Date
- 2021-11-01
- Public Version Status
- Update
- Public Device Record Key
- 5725df5e-58d5-4854-ace6-bd3c07b51bec
Device Description
TRUEcontrol Solution Level 2
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00021292008376 | 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
- 36 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- DO NOT REFRIGERATE OR FREEZE