TRUEcontrol
GUDID 00021292002091
TRUEcontrol Solution Level 0
TRIVIDIA HEALTH, INC.
Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control| Primary Device ID | 00021292002091 |
| NIH Device Record Key | 8668f78d-926d-4a4a-b6c5-fd2102a01a8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRUEcontrol |
| Version Model Number | TRUEcontrol Solution Level 0 |
| Company DUNS | 151810868 |
| Company Name | TRIVIDIA HEALTH, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00021292002091 [Package] Contains: 00021292008383 Package: BOX [1 Units] In Commercial Distribution |
| GS1 | 00021292008383 [Primary] |
| GS1 | 10021292002098 [Package] Package: CASE [400 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032657
FDA Product Code
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-08 |
| Device Publish Date | 2021-01-29 |
On-Brand Devices [TRUEcontrol]
| 00021292002091 | TRUEcontrol Solution Level 0 |
| 00021292008376 | TRUEcontrol Solution Level 2 |
| 00021292002107 | TRUEcontrol Solution Level 1 |
Trademark Results [TRUEcontrol]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUECONTROL 88644691 not registered Live/Pending |
RHA Technologies Ltd 2019-10-07 |
 TRUECONTROL 88045085 not registered Dead/Abandoned |
Mediashift Technologies, Inc. 2018-07-19 |
 TRUECONTROL 86170835 4683768 Live/Registered |
TRIVIDIA HEALTH, INC. 2014-01-21 |
 TRUECONTROL 85229781 not registered Dead/Abandoned |
Savant Systems LLC 2011-01-31 |
 TRUECONTROL 78520242 3041351 Dead/Cancelled |
Rendition Networks, Inc. 2004-11-19 |
 TRUECONTROL 78025355 not registered Dead/Abandoned |
Abbott Laboratories 2000-09-11 |
 TRUECONTROL 77365927 3515317 Dead/Cancelled |
NIPRO DIAGNOSTICS, INC. 2008-01-07 |
 TRUECONTROL 77172892 3368510 Dead/Cancelled |
NIPRO DIAGNOSTICS, INC. 2007-05-04 |
 TRUECONTROL 76481894 not registered Dead/Abandoned |
Rendition Networks, Inc. 2003-01-13 |
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