Scan

GUDID 00863398000294

Blood glucose meter.

LEXINGTON WELLNESS HOLDINGS INC.

Glucose monitoring system IVD, home-use
Primary Device ID00863398000294
NIH Device Record Keyb0613c4c-0892-4980-87d5-b7f41e86086e
Commercial Distribution StatusIn Commercial Distribution
Brand NameScan
Version Model NumberG-427B
Company DUNS079437338
Company NameLEXINGTON WELLNESS HOLDINGS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
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
GS100863398000294 [Primary]
GS120863398000298 [Package]
Package: Inner Pack [10 Units]
In Commercial Distribution
GS130863398000295 [Package]
Contains: 20863398000298
Package: Case [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-09
Device Publish Date2021-02-01

On-Brand Devices [Scan]

00863398000294Blood glucose meter.
00860005561704Blood glucose meter test strips.

Trademark Results [Scan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SCAN
SCAN
90673691 not registered Live/Pending
Simple Design Ltd.
2021-04-27
SCAN
SCAN
90025854 not registered Live/Pending
LARTA INSTITUTE
2020-06-29
SCAN
SCAN
87408188 not registered Dead/Abandoned
HKScan Sweden AB
2017-04-12
SCAN
SCAN
85880689 4606392 Live/Registered
Scan, Inc.
2013-03-20
SCAN
SCAN
85880687 4606391 Live/Registered
Scan, Inc.
2013-03-20
SCAN
SCAN
85600050 not registered Dead/Abandoned
Piccionelli, Gregory A.
2012-04-17
SCAN
SCAN
85600050 not registered Dead/Abandoned
D'Amore, Brandon
2012-04-17
SCAN
SCAN
85424705 not registered Dead/Abandoned
CLEARONE, INC.
2011-09-16
SCAN
SCAN
81036155 1036155 Dead/Cancelled
Ohio-Nuclear, Inc.
0000-00-00
SCAN
SCAN
80983192 0983192 Dead/Cancelled
Mentoris Company
0000-00-00
SCAN
SCAN
79214731 5494603 Live/Registered
HAWAII FURNISHING PTE LTD
2017-05-05
SCAN
SCAN
79048966 3493001 Dead/Cancelled
Scan A/S
2007-12-04

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