FDA.reportPublic FDA data

AUVON

Primary DI
16971292001437
Brand
AUVON
Company
Shenzhen Yuwen E-Commerce Co., Ltd.
Model
TS1111011
Device description
The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample.
Published
2022-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
16971292001437PackageGS175In Commercial Distribution
06971292001430PrimaryGS10
06971292001133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697129200143716971292001437
06971292001430069712920014306971292001430
06971292001133069712920011336971292001133

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, enzyme spectrophotometry, rapidA collection of reagents, and sometimes other associated materials, intended to be used for the quantitative measurement of glucose in a clinical specimen within a short period relative to standard laboratory testing procedures, using an enzyme spectrophotometry method. It is available in a variety of forms (e.g., strips, cartridges, micro-cassettes) and may be used in the laboratory, at the point-of-care, and/or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544559614
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
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
06971292003915AUVONTU10802025-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16945630137799STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16945630137805STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16945630137812STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16945630137829STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-04-19
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
16945630141987STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
16945630141994STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
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
16931918130408Cardinal HealthGRI Medical & Electronic Technology Co., Ltd.FMK2025-06-20
16931918166803Cardinal HealthGRI Medical & Electronic Technology Co., Ltd.FMK2025-06-20
16945630132435STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23
16945630132442STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23
16945630132466STERiLANCE Elite Disposable Safety LancetSterilance Medical (Suzhou) Inc.FMK2024-10-23