FDA.reportPublic FDA data

TRUEplus

Primary DI
00021292010300
Brand
TRUEplus
Company
TRIVIDIA HEALTH, INC.
Model
TRUEplus Sterile Pen Needles
Catalog number
S5H01D31-050
Device description
"TRUEplus Pen Needles 31G x 5/16"""
Published
2017-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143437000Droplet Pen NeedlesHtl-Strefa S.A2015-06-25FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10021292010307PackageGS145In Commercial Distribution
00021292010300PrimaryGS10
00021292009014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002129201030710021292010307
00021292010300000212920103000212920103000021292010300
00021292009014000212920090140212920090140021292009014

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.16Inch
Needle Gauge31Gauge

Contacts#

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

Regulatory Flags#

DUNS number
151810868
Device count
50
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

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