TRUEdraw M2H01-81
GUDID 10021292142015
TRUEdraw Lancing Device
TRIVIDIA HEALTH, INC.
Manual blood lancing device, reusable| Primary Device ID | 10021292142015 |
| NIH Device Record Key | 62b07a06-a732-4c99-b7aa-d40a11900f43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRUEdraw |
| Version Model Number | TRUEdraw Lancing Device |
| Catalog Number | M2H01-81 |
| Company DUNS | 151810868 |
| Company Name | TRIVIDIA HEALTH, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Store without a lancet inserted. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00021292142018 [Primary] |
| GS1 | 10021292142015 [Package] Contains: 00021292142018 Package: case [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221072
FDA Product Code
| FMK | Lancet, Blood |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only |
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 | 2020-12-22 |
| Device Publish Date | 2020-12-14 |
On-Brand Devices [TRUEdraw]
| 10087701526203 | Good Neighbor Lancing Device |
| 10052569138424 | HealthMart TRUEdraw Lancing Device |
| 10021292142015 | TRUEdraw Lancing Device |
| 10011822741085 | Rite Aid TRUEdraw Lancing Device |
| 10010939709445 | Sunmark TRUEdraw Lancing Device |
| 10050428645946 | CVS Lancing Device |
| 10010939958683 | Foster & Thrive TRUEdraw Lancing Device |
Trademark Results [TRUEdraw]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUEDRAW 85376398 4208769 Live/Registered |
TRIVIDIA HEALTH, INC. 2011-07-20 |
 TRUEDRAW 77724652 3804499 Live/Registered |
TRIVIDIA HEALTH, INC. 2009-04-29 |
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