TRUEplus

Primary DI
00021292005863
Brand
TRUEplus
Company
TRIVIDIA HEALTH, INC.
Model
TRUEplus SINGLE-USE INSULIN syringes 31 gauge need
Device description
TRUEplus SINGLE-USE INSULIN syringes 31 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
00010939695444PackageGS110In Commercial Distribution
00010939958730PackageGS110In Commercial Distribution
00021292005030PackageGS110In Commercial Distribution
00021292007362PackageGS110Not in Commercial Distribution
00036800234475PackageGS110In Commercial Distribution
00041260385100PackageGS110In Commercial Distribution
00052569138137PackageGS110In Commercial Distribution
00087701426155PackageGS110In Commercial Distribution
00096295125405PackageGS110In Commercial Distribution
10010939695441PackageGS18In Commercial Distribution
10010939958737PackageGS18In Commercial Distribution
10021292005037PackageGS18In Commercial Distribution
10021292007369PackageGS18Not in Commercial Distribution
10036800234472PackageGS18In Commercial Distribution
10041260385107PackageGS18In Commercial Distribution
10052569138134PackageGS18In Commercial Distribution
10087701426152PackageGS18In Commercial Distribution
50096295125400PackageGS18In Commercial Distribution
00021292005863PrimaryGS10
00021292007980Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00010939695444000109396954440109396954440010939695444
00010939958730000109399587300109399587300010939958730
00021292005030000212920050300212920050300021292005030
00021292007362000212920073620212920073620021292007362
00036800234475000368002344750368002344750036800234475
00041260385100000412603851000412603851000041260385100
00052569138137000525691381370525691381370052569138137
00087701426155000877014261550877014261550087701426155
00096295125405000962951254050962951254050096295125405
1001093969544110010939695441
1001093995873710010939958737
1002129200503710021292005037
1002129200736910021292007369
1003680023447210036800234472
1004126038510710041260385107
1005256913813410052569138134
1008770142615210087701426152
5009629512540050096295125400
00021292005863000212920058630212920058630021292005863
00021292007980000212920079800212920079800021292007980

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 Gauge31Gauge
Total Volume0.3Milliliter

Sterilization Methods#

Method table
Method

Contacts#

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

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Primary DI, Brand, Company table
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