DKK

GUDID 16939184627103

Blood glucose monitoring system, it contains blood glucose meter, blood glucose test strips, lancing device and sterile lancet.

Bioland Technology Ltd.

Glucose monitoring system IVD, home-use
Primary Device ID16939184627103
NIH Device Record Key27b4174c-f5e6-4b47-a0bf-6ba0c537d1a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDKK
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106939184627106 [Primary]
GS116939184627103 [Package]
Contains: 06939184627106
Package: [10 Units]
In Commercial Distribution
GS126939184627100 [Package]
Package: [2 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 Date2021-07-26
Device Publish Date2021-07-16

Devices Manufactured by Bioland Technology Ltd.

16939184642526 - Bioland2024-04-03 Bioland G-425-2 Blood Glucose Monitoring System
16939184601356 - Glucoracy2024-04-02 Glucoracy G-425-2S Blood Glucose Test Strips
16939184610723 - INSMART2023-11-09 Blood Pressure Monitor
16939184600946 - Glucoracy2023-10-16 Glucoracy GLUCOSE CONTROL SOLUTION
16939184630899 - Glucoracy2023-10-16 Glucoracy G-427B Blood Glucose Monitoring System
16939184630882 - Glucoracy2023-09-27 Glucoracy G-425-2 Blood Glucose Monitoring System
16939184600359 - ELERA2023-08-23 Blood Glucose Test Strips
16939184600489 - Glucoracy2023-08-23 Glucoracy G-425-2S Blood Glucose Test Strips

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