TRUEplus

Primary DI
00021292005856
Brand
TRUEplus
Company
TRIVIDIA HEALTH, INC.
Model
TRUEplus SINGLE-USE INSULIN syringes 30 gauge need
Device description
TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 1.0cc insulin
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993017000PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGEShinchang Medical Co., Ltd.2000-02-25FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00010939698445PackageGS110Not in Commercial Distribution
00021292005023PackageGS110In Commercial Distribution
00021292007355PackageGS110Not in Commercial Distribution
00041260385094PackageGS110In Commercial Distribution
00052569138144PackageGS110Not in Commercial Distribution
00087701426148PackageGS110In Commercial Distribution
00096295125399PackageGS110In Commercial Distribution
10010939698442PackageGS18Not in Commercial Distribution
10021292005020PackageGS18In Commercial Distribution
10021292007352PackageGS18Not in Commercial Distribution
10041260385091PackageGS18In Commercial Distribution
10052569138141PackageGS18Not in Commercial Distribution
10087701426145PackageGS18In Commercial Distribution
50096295125394PackageGS18In Commercial Distribution
00021292005856PrimaryGS10
00021292008055Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00010939698445000109396984450109396984450010939698445
00021292005023000212920050230212920050230021292005023
00021292007355000212920073550212920073550021292007355
00041260385094000412603850940412603850940041260385094
00052569138144000525691381440525691381440052569138144
00087701426148000877014261480877014261480087701426148
00096295125399000962951253990962951253990096295125399
1001093969844210010939698442
1002129200502010021292005020
1002129200735210021292007352
1004126038509110041260385091
1005256913814110052569138141
1008770142614510087701426145
5009629512539450096295125394
00021292005856000212920058560212920058560021292005856
00021292008055000212920080550212920080550021292008055

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.31Inch
Needle Gauge30Gauge
Total Volume1Milliliter

Contacts#

Phone, Email table
PhoneEmail
+1(800)803-6025customercare@trividiahealth.com

Regulatory Flags#

DUNS number
151810868
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428167243TRUEplusCVS TRUEplus 5-bevel Pen Needle 31G 5mm - 50ct - nS6007B31-502026-10-07
00050428167267TRUEplusTRUEplus 5-bevel Pen Needle 32G 4mmS6007A32-502026-10-07
00050428167281TRUEplusTRUEplus Sterile LancetsS1007DB30-1002026-08-14
00050428167298TRUEdrawCVS TRUEdraw Lancing DeviceS3007-012026-08-14
00050428167304TRUEplusTRUEplus Sterile LancetsS1007LB28-1002026-08-14
00050428167311TRUEplusTRUEplus Sterile LancetsS1007YL33-1002026-08-14
00050428167328TRUEplusTRUEplus Sterile LancetsS1007DB30-2002026-08-14
00050428167380TRUEplusTRUEplus Sterile LancetsS1007YL33-2002026-08-14
00050428324073TRUEplusTRUEplus 5-bevel Pen Needle 32G 4mmS6007A32-1002026-03-17
10050428324070TRUEplusTRUEplus 5-bevel Pen Needle 32G 4mmS6007A32-1002026-03-17
00041260007354TRUE METRIX AIRTRUE METRIX AIR Self Monitoring Blood Glucose MeteREA4203-012026-02-09
10041260007351TRUE METRIX AIRTRUE METRIX AIR Self Monitoring Blood Glucose MeteREA4203-012026-02-09
00021292015381TRUE METRIX PROTRUE METRIX PRO Professional Blood Glucose Monitor2025-12-02
10840330705698TRUE METRIX PROTRUE METRIX PRO Professional Blood Glucose Monitor2025-12-02
00075450843576TRUE METRIX GOTRUE METRIX GO Self-Monitoring Blood Glucose MeterRF4048-012025-11-26
10075450843573TRUE METRIX GOTRUE METRIX GO Self-Monitoring Blood Glucose MeterRF4048-012025-11-26
10840330706541TRUE METRIXTRUE METRIX Control Solution - Level 1 and Level 3R5212-132025-11-25
30840330706545TRUE METRIXTRUE METRIX Control Solution - Level 1 and Level 3R5212-132025-11-25
00021292009120TRUE METRIXTRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STR2016-09-24
00021292007256TRUE METRIXTRUE METRIX SELF MONITORING BLOOD GLUCOSE METER RE4023-012016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193867Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194109Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194116Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194208Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194215Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194222Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194239Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194246Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194253Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194260Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194277Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194284Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194291Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194307Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194314Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
05391530753982polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530753999polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530754408polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530754439polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01
05391530754750polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-10-01