FDA.reportPublic FDA data

AUVON

Primary DI
06971292003502
Brand
AUVON
Company
Shenzhen Yuwen E-Commerce Co., Ltd.
Model
I
Catalog number
LD2111012
Device description
The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.This system is for use only on a single patient in a home setting.This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
Published
2025-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971292003509PackageGS1125In Commercial Distribution
06971292003502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697129200350916971292003509
06971292003502069712920035026971292003502

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(678)829-7256support@iauvon.com

Regulatory Flags#

DUNS number
544559614
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971292004318AUVONEP3M122026-07-13
06971292004301AUVONTC32412026-01-21
06971292004295AUVONTU24242025-12-17
06971292004127AUVONTC32412025-09-22
06971292004110AUVONTP2408C2025-09-19
16971292004117AUVONTP2408C2025-09-19
06971292004103AUVONTU10802025-09-11
06971292008071AUVONTA22242025-09-02
16971292008078AUVONTA22242025-09-02
06971292008064AUVONTP22082025-08-12
06971292003939AUVONEB15202025-07-16
06971292003946AUVONEB15202025-07-16
06971292003953AUVONEB15482025-07-16
06971292003960AUVONEB15202025-07-16
06971292003977AUVONEB15202025-07-16
16971292003936AUVONEB15202025-07-16
16971292003943AUVONEB15202025-07-16
16971292003950AUVONEB15482025-07-16
16971292003967AUVONEB15202025-07-16
16971292003974AUVONEB15202025-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196395811MEDLINEMEDLINE INDUSTRIES, INC.QRK2026-07-22
06949517010017medisanaShandong Lianfa Medical Plastic Products CO.,LTDQRK2026-07-14
06949517010024medisanaShandong Lianfa Medical Plastic Products CO.,LTDQRK2026-07-14
00810011730755leraiseTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810011730755leraiseTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00810011730779VivaGuardTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810011730779VivaGuardTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00810011730786VivaGuardTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00810011730793HuahongTianjin Huahong Technology Co., Ltd.QRK2026-07-10
00810011730793HuahongTianjin Huahong Technology Co., Ltd.QRL2026-07-10
00194631000079Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-09
00194631000024Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000031Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000048Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00194631000062Right LanceBeijing Ruicheng Medical Supplies Co., Ltd.QRL2026-06-08
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
00301936020217MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
00301936021214MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
16945630142007STERiLANCESterilance Medical (Suzhou) Inc.QRL2026-03-09
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
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
MHC1808002EasyTouchMHC MEDICAL PRODUCTS, LLCQRL2025-11-10