TRUEplus
GUDID 00021292005849
TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 0.5cc insulin
TRIVIDIA HEALTH, INC.
Insulin syringe/needle, basic| Primary Device ID | 00021292005849 |
| NIH Device Record Key | 6d2bdd98-c444-4498-8c40-e4c3112b9de2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRUEplus |
| Version Model Number | TRUEplus SINGLE-USE INSULIN syringes 30 gauge need |
| Company DUNS | 151810868 |
| Company Name | TRIVIDIA HEALTH, INC. |
| Device Count | 10 |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com | |
| Phone | +1(800)803-6025 |
| customercare@trividiahealth.com |
Device Dimensions
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
| Length | 0.31 Inch |
| Total Volume | 0.5 Milliliter |
| Needle Gauge | 30 Gauge |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00010939697448 [Package] Package: Box [10 Units] Discontinued: 2024-08-28 Not in Commercial Distribution |
| GS1 | 00021292005016 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00021292005849 [Primary] |
| GS1 | 00021292007348 [Package] Package: Box [10 Units] Discontinued: 2018-04-16 Not in Commercial Distribution |
| GS1 | 00021292008017 [Unit of Use] |
| GS1 | 00041260385087 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00052569138151 [Package] Package: Box [10 Units] Discontinued: 2024-08-28 Not in Commercial Distribution |
| GS1 | 00087701426131 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00096295125382 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 10010939697445 [Package] Contains: 00010939697448 Package: Case [8 Units] Discontinued: 2024-08-28 Not in Commercial Distribution |
| GS1 | 10021292005013 [Package] Contains: 00021292005016 Package: Case [8 Units] In Commercial Distribution |
| GS1 | 10021292007345 [Package] Contains: 00021292007348 Package: Case [8 Units] Discontinued: 2018-04-16 Not in Commercial Distribution |
| GS1 | 10041260385084 [Package] Contains: 00041260385087 Package: Case [8 Units] In Commercial Distribution |
| GS1 | 10052569138158 [Package] Contains: 00052569138151 Package: Case [8 Units] Discontinued: 2024-08-28 Not in Commercial Distribution |
| GS1 | 10087701426138 [Package] Contains: 00087701426131 Package: Case [8 Units] In Commercial Distribution |
| GS1 | 50096295125387 [Package] Contains: 00096295125382 Package: Case [8 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993017
FDA Product Code
| FMF | Syringe, Piston |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-08-30 |
| Device Publish Date | 2016-09-20 |
On-Brand Devices [TRUEplus]
| 50096295129132 | LEADER TRUEplus Pen Needles 32 GAUGE x 5/32" |
| 50096295129125 | LEADER TRUEplus Pen Needles 31 GAUGE x 5/16" |
| 50096295129118 | LEADER TRUEplus Pen Needles 31 GAUGE x 1/4" |
| 50096295129101 | LEADER TRUEplus Pen Needles 31 GAUGE x 3/16" |
| 50096295129095 | LEADER TRUEplus Pen Needles 29 GAUGE x 1/2" |
| 00021292005887 | TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 1.0cc insulin |
| 00021292005870 | TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 0.5cc insulin |
| 00021292005863 | TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 0.3cc insulin |
| 10036800234502 | TopCare TRUEplus 3-Bevel Pen Needles 31G/8mm 100ct box - Tae Chang |
| 10021292009066 | TRUEplus STERILE pen needles 31 GAUGE x 5/16" |
| 10021292009059 | TRUEplus STERILE pen needles 31 GAUGE x 1/4" |
| 10021292009035 | TRUEplus STERILE pen needles 29 GAUGE x 1/2" |
| 10021292009073 | TRUEplus STERILE pen needles 32 GAUGE x 5/32" |
| 10021292009042 | TRUEplus STERILE pen needles 31 GAUGE x 3/16" |
| 00311917173900 | TRUEplus Ketone Test Strips |
| 10021292010536 | TRUEplus Safety Lancets |
| 10021292010529 | TRUEplus Safety Lancets |
| 10011822463307 | Rite Aid TRUEplus Safety Lancets |
| 10087701426060 | Good Neighbor Pharmacy TRUEplus Sterile Lancets |
| 10087701426053 | Good Neighbor Pharmacy TRUEplus Sterile Lancets |
| 10087701426046 | Good Neighbor Pharmacy TRUEplus Sterile Lancets |
| 10052569138196 | HealthMart TRUEplus Sterile Lancets |
| 10052569138189 | HealthMart TRUEplus Sterile Lancets |
| 10052569138172 | HealthMart TRUEplus Sterile Lancets |
| 10036800234465 | TopCare TRUEplus Sterile Lancets |
| 10021292010512 | TRUEplus Sterile Lancets |
| 10021292004481 | TRUEplus Sterile Lancets |
| 10021292004467 | TRUEplus Sterile Lancets |
| 10021292000223 | TRUEplus Sterile Lancets |
| 10011822741122 | Rite Aid TRUEplus lancets |
| 10011822741115 | Rite Aid TRUEplus lancets |
| 10011822741108 | Rite Aid TRUEplus lancets |
| 10011822741092 | Rite Aid TRUEplus lancets |
| 10010939702446 | Sunmark TRUEplus Sterile Lancets |
| 10010939701449 | Sunmark TRUEplus Sterile Lancets |
| 10010939700442 | Sunmark TRUEplus Sterile Lancets |
| 10021292010314 | TRUEplus Pen Needles 32G x 5/32" |
| 10021292014787 | 5-bevel V TRUEplus Pen Needle 32G/4mm - 100ct box |
| 10021292014770 | 5-bevel V TRUEplus Pen Needle 31G/8mm - 100ct box |
| 10021292014763 | 5-bevel V TRUEplus Pen Needle 31G/6mm - 100ct box |
| 10021292014756 | 5-bevel V TRUEplus Pen Needle 31G/5mm - 100ct box |
| 10050428651077 | CVS lancets - 30G 100ct |
| 10050428648824 | CVS Lancets - 28G 100ct |
| 10050428648770 | CVS lancets - 33G 200ct |
| 10050428647537 | CVS lancets - 33G 100ct |
| 10050428646776 | CVS lancets - 30G 200ct |
| 10050428647551 | CVS TRUEplus Pen Needles - 5- Bevel - 32G 4mm |
| 10050428646066 | CVS TRUEplus Pen Needles - 5- Bevel - 31G 5mm |
| 10311917136346 | Walgreens TRUEplus Pen Needles 5Bevel - 32G 4mm - 50ct box |
| 10311917136339 | Walgreens TRUEplus Pen Needles -5Bevel - 31G 5mm - 50ct box |
Trademark Results [TRUEplus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUEPLUS 90874116 not registered Live/Pending |
Trividia Health, Inc. 2021-08-10 |
 TRUEPLUS 90874111 not registered Live/Pending |
Trividia Health, Inc. 2021-08-10 |
 TRUEPLUS 86299702 4937398 Live/Registered |
TRIVIDIA HEALTH, INC. 2014-06-04 |
 TRUEPLUS 86299700 4928165 Live/Registered |
TRIVIDIA HEALTH, INC. 2014-06-04 |
 TRUEPLUS 85680430 4471764 Live/Registered |
TRIVIDIA HEALTH, INC. 2012-07-18 |
 TRUEPLUS 85680247 4475783 Live/Registered |
TRIVIDIA HEALTH, INC. 2012-07-18 |
 TRUEPLUS 85081521 not registered Dead/Abandoned |
Nipro Diagnostics, Inc. 2010-07-09 |
 TRUEPLUS 85081510 not registered Dead/Abandoned |
Nipro Diagnostics, Inc. 2010-07-09 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.