FDA.report

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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850080988091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080988091008500809880918500809880910850080988091

GMDN Terms

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

Contacts

PhoneEmail
+1(678)829-7256support@iauvon.com

Regulatory Flags

DUNS number
765349382
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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 DIBrandModelCatalogPublished
00850080988466AUVONTA22242026-05-24
10850080988142AUVONTX62242026-03-23
10850080988135AUVONTP2408C2026-03-19
00850080988107AUVONDS-W2026-03-02
00850080988114AUVONDS-W2026-03-02
00850080988121AUVONEB15482026-03-02
00850080988046AUVONDS-W2026-02-06
00850080988077AUVONDS-W2026-02-06

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