FDA.reportPublic FDA data

TRUEplus

Primary DI
00021292005832
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 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
00010939699442PackageGS110In Commercial Distribution
00021292005009PackageGS110In Commercial Distribution
00021292007331PackageGS110Not in Commercial Distribution
00041260385070PackageGS110In Commercial Distribution
00052569138168PackageGS110In Commercial Distribution
00087701426124PackageGS110In Commercial Distribution
00096295125375PackageGS110In Commercial Distribution
10010939699449PackageGS18In Commercial Distribution
10021292005006PackageGS18In Commercial Distribution
10021292007338PackageGS18Not in Commercial Distribution
10041260385077PackageGS18In Commercial Distribution
10052569138165PackageGS18In Commercial Distribution
10087701426121PackageGS18In Commercial Distribution
50096295125370PackageGS18In Commercial Distribution
00021292005832PrimaryGS10
00021292007973Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00010939699442000109396994420109396994420010939699442
00021292005009000212920050090212920050090021292005009
00021292007331000212920073310212920073310021292007331
00041260385070000412603850700412603850700041260385070
00052569138168000525691381680525691381680052569138168
00087701426124000877014261240877014261240087701426124
00096295125375000962951253750962951253750096295125375
1001093969944910010939699449
1002129200500610021292005006
1002129200733810021292007338
1004126038507710041260385077
1005256913816510052569138165
1008770142612110087701426121
5009629512537050096295125370
00021292005832000212920058320212920058320021292005832
00021292007973000212920079730212920079730021292007973

Device Sizes#

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

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