TRUEdraw S3089-01
GUDID 10052569138424
HealthMart TRUEdraw Lancing Device
TRIVIDIA HEALTH, INC.
Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable| Primary Device ID | 10052569138424 |
| NIH Device Record Key | 7da28937-40a9-431d-b422-36139ebb1f3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRUEdraw |
| Version Model Number | HealthMart TRUEdraw Lancing Device |
| Catalog Number | S3089-01 |
| 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 | 00052569138427 [Primary] |
| GS1 | 10052569138424 [Package] Contains: 00052569138427 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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