Wellue

GUDID 16934440100000

Blood Glucose Meter

Bioland Technology Ltd.

Glucose analyser IVD, home-use
Primary Device ID16934440100000
NIH Device Record Keycb428e9a-15c8-452d-8c9b-084883c8040b
Commercial Distribution StatusIn Commercial Distribution
Brand NameWellue
Version Model NumberG-427B
Company DUNS545852548
Company NameBioland Technology Ltd.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106934440101093 [Primary]
GS116934440100000 [Package]
Contains: 06934440101093
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-28
Device Publish Date2021-01-20

On-Brand Devices [Wellue]

16934440100017Blood Glucose Test Strips
16934440100000Blood Glucose Meter

Trademark Results [Wellue]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WELLUE
WELLUE
88208986 5910149 Live/Registered
Shenzhen Viatom Technology Co., Ltd.
2018-11-28
WELLUE
WELLUE
77524402 not registered Dead/Abandoned
Cleveland Clinic Foundation
2008-07-17

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