COLEBY

GUDID 16939184630233

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 ID16939184630233
NIH Device Record Key3ee4b535-8433-49f5-b990-29c8f8cf502a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOLEBY
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106939184630236 [Primary]
GS116939184630233 [Package]
Contains: 06939184630236
Package: [20 Units]
In Commercial Distribution
GS126939184630230 [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 Date2021-11-15
Device Publish Date2021-11-05

On-Brand Devices [COLEBY]

16939184630233Blood glucose monitoring system, it contains blood glucose meter, blood glucose test strips, lan
16939184610129Portable Wrist Blood Pressure Monitor

Trademark Results [COLEBY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COLEBY
COLEBY
90205975 not registered Live/Pending
Dongguan Hongtailong Warehousing Service Co., Ltd.
2020-09-24

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