FDA.reportPublic FDA data

TRUEplus

Primary DI
10011822463307
Brand
TRUEplus
Company
TRIVIDIA HEALTH, INC.
Model
Rite Aid TRUEplus Safety Lancets
Catalog number
S7066RN28-25
Device description
Rite Aid TRUEplus Safety Lancets
Published
2020-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKLancet, Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10011822463307PackageGS124In Commercial Distribution
00011822463300PrimaryGS10
00021292012458Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001182246330710011822463307
00011822463300000118224633000118224633000011822463300
00021292012458000212920124580212920124580021292012458

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, single-useA sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge28Gauge

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
151810868
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
Primary DIBrandCompanyProduct codePublished
00199536930407BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930414BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930421BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393415Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393422Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393439Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393460Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393477Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393484Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20