FDA.reportPublic FDA data

AUVON

Primary DI
00850080988091
Brand
AUVON
Company
UAN HEALTHCARE LIMITED
Model
DS-W
Device description
100 test strips for blood sugar + 100 blood collection needles set.
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter
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
CGAGlucose Oxidase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2
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
00850080988091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080988091008500809880918500809880910850080988091

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
765349382
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080988466AUVONTA22242026-05-24
00850080988435AUVONTA22242026-05-21
00850080988442AUVONTX62242026-05-21
00850080988459AUVONTX62242026-05-21
00850080988428AUVONDS-W2026-05-09
00850080988411AUVONTU24242026-05-06
00850080988381AUVONTA22242026-04-29
00850080988398AUVONTX62242026-04-29
00850080988404AUVONTP2208C2026-04-29
00850080988206AUVONEB15202026-04-07
00850080988213AUVONEB1M202026-04-07
00850080988190AUVONEB15202026-03-30
00850080988152AUVONEB1M202026-03-27
00850080988169AUVONEB10102026-03-27
00850080988176AUVONEB15202026-03-27
00850080988183AUVONEB15202026-03-27
00850080988145AUVONTX62242026-03-23
10850080988142AUVONTX62242026-03-23
00850080988138AUVONTP2408C2026-03-19
10850080988135AUVONTP2408C2026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393415Sterilized Eol Auto LancetHLB CO.,LTDQRK2025-08-20
08809262393422Sterilized Eol Auto LancetHLB CO.,LTDQRK2025-08-20
08809262393439Sterilized Eol Auto LancetHLB CO.,LTDQRK2025-08-20
08809262393460Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393477Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393484Sterilized Eol Lancet PlusHLB CO.,LTDQRK2025-08-20
08809262393743SureComfort Safety LancetHLB CO.,LTDQRK2025-08-20
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
10673486002478GLUCOPAD TC-SMART+ Lancets KitTECO DIAGNOSTICSQRK2025-06-10
10673486002461GLUCOPAD TC-SMART+ Lancets KitTECO DIAGNOSTICSQRK2025-05-14
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27