FDA.reportPublic FDA data

Premier Value Unilet Lancets

Primary DI
00840986016684
Brand
Premier Value Unilet Lancets
Company
PHARMACY VALUE ALLIANCE, LLC
Model
AT 0575CDC
Device description
Premier Value Unilet Lancets Super Thin 30 gauge
Published
2023-01-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00761059577287PackageGS1200Not in Commercial Distribution
00840986016684PrimaryGS10
00384700575007Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059577287007610595772877610595772870761059577287
00840986016684008409860166848409860166840840986016684
00384700575007003847005750073847005750070384700575007

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancing device tipA sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge0

Regulatory Flags#

DUNS number
089138159
Device count
100
DM exempt
false
Premarket exempt
false
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
00840986015854PREMIER VALUEF408-150CD2020-09-21
00840986016196Premier Value TamponsBPVAR402016-09-20
00840986016202Premier Value TamponsBPVAS402016-09-20
00840986016219Premier Value TamponsBPVAP402016-09-20
00840986016431PREMIER VALUE71091CD2020-09-21
00840986016516PREMIER VALUE67830CD2020-09-21
00840986016547PREMIER VALUE97205CD2020-09-21
00840986016639Premier ValueOne Step Pregnancy Test2016-08-30
00840986016646Premier ValueOne Step Pregnancy Test2016-08-30
00840986021091Premier ValueEarly Result Pregnancy Test2016-08-30
00840986026850Premier Value TamponsBPVGS182016-09-20
00840986026867Premier Value TamponsBPVGC362016-09-20
00840986030123Premier Value30122017-06-23
00840986032837Premier Value Unilet LancetsAT 0585CDC2023-01-06
00840986034992Premier Value AutoletAT 0270CDC2023-02-03
00840986036781CDC- Premier Value- 33G x 4mm pen needles w/removerAN 3860CDCAN 3860CDC2021-05-25
00840986037009Premier ValueOne Step Pregnancy Test2020-09-21
00840986010095PREMIER93965HZ93965HZ2016-09-20
00840986023675CDC - Premier Value - 31Gx6mm pen needles w/removerAN 3890CDCAN 3890CDC2016-09-19
00840986023682CDC - Premier Value - 31Gx8mm pen needles w/removerAN 3830CDCAN 3830CDC2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
00860015786838True IntegralTRUE INTEGRAL INCQRK2026-05-20
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-09
00850080988428AUVONUAN HEALTHCARE LIMITEDQRK2026-05-09
00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-06
00860015383969True IntegralTRUE INTEGRAL INCQRK2026-04-14
00682607541072On Call Lancets (33G)Acon Laboratories, Inc.QRK2026-03-30
00301936020217MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
00301936021214MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
16945630142014STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142021STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142038STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142045STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142069STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
00197344174433CARINGMEDLINE INDUSTRIES, INC.QRK2026-03-03
00850080988107AUVONUAN HEALTHCARE LIMITEDQRK2026-03-02
00850080988114AUVONUAN HEALTHCARE LIMITEDQRK2026-03-02
00682607541058On Call Lancets 30GAcon Laboratories, Inc.QRK2026-02-19
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
00810079240609Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
00850080988091AUVONUAN HEALTHCARE LIMITEDQRK2026-02-06
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
00810011730649HuahongTianjin Huahong Technology Co., Ltd.QRK2025-12-24
MHC1826101EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-11-10
20197344111838MEDLINEMEDLINE INDUSTRIES, INC.QRK2025-10-22
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRK2025-09-17