FDA.reportPublic FDA data

TRUEplus

Primary DI
00021292005801
Brand
TRUEplus
Company
TRIVIDIA HEALTH, INC.
Model
TRUEplus SINGLE-USE INSULIN syringes 29 gauge need
Device description
TRUEplus SINGLE-USE INSULIN syringes 29 gauge needle 0.3cc 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
00021292004972PackageGS110In Commercial Distribution
00021292007300PackageGS110Not in Commercial Distribution
00087701426094PackageGS110Not in Commercial Distribution
10021292004979PackageGS18In Commercial Distribution
10021292007307PackageGS18Not in Commercial Distribution
10087701426091PackageGS18Not in Commercial Distribution
00021292005801PrimaryGS10
00021292007966Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00021292004972000212920049720212920049720021292004972
00021292007300000212920073000212920073000021292007300
00087701426094000877014260940877014260940087701426094
1002129200497910021292004979
1002129200730710021292007307
1008770142609110087701426091
00021292005801000212920058010212920058010021292005801
00021292007966000212920079660212920079660021292007966

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
Length0.5Inch
Needle Gauge29Gauge
Total Volume0.3Milliliter

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
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
00021292007843TRUE METRIXTRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRR3NPD03, RF3TVH702016-09-20
00021292007874TRUE METRIX PROTRUE METRIX PRO BLOOD GLUCOSE TEST STRIPS - 10 Tes2016-09-20
00021292012236TRUE METRIXTRUE METRIX Self Monitoring Blood Glucose Test Str2018-02-01
00021292012779TRUEplusTRUEplus 3-Bevel Pen Needle 29G/12mm - 100ct boxS5H01F29-100TC2019-02-20
00021292012786TRUEplusTRUEplus 3-Bevel Pen Needle 31G/5mm - 100ct boxS5H01B31-100TC2019-02-20
00021292012793TRUEplusTRUEplus 3-Bevel Pen Needle 31G/6mm - 100ct boxS5H01C31-100TC2019-02-20
00021292012809TRUEplusTRUEplus 3-Bevel Pen Needle 31G/8mm - 100ct boxS5H01D31-100TC2019-02-20
00021292012816TRUEplusTRUEplus 3-Bevel Pen Needle 32G/4mm - 100ct boxS5H01A32-100TC2019-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
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10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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