FDA.reportPublic FDA data

GLUCOCARD® Shine XL Blood Glucose Monitoring System

Primary DI
00015482542108
Brand
GLUCOCARD® Shine XL Blood Glucose Monitoring System
Company
ARKRAY USA, INC.
Model
542110
Device description
The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
Published
2017-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083468000CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)I-Sens, Inc.2009-02-10NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10015482542105PackageGS14In Commercial Distribution
20015482542102PackageGS116In Commercial Distribution
00015482542108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001548254210510015482542105
2001548254210220015482542102
00015482542108000154825421080154825421080015482542108

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-566-8558xxx@xxx.xxx

Regulatory Flags#

DUNS number
008171162
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04987486053002S.G. Calibrator H111581N/A2025-12-19
00015482104658AUTION MAX™ AX-4060 Analyzer1005262025-11-07
00015482510060Assure® Control - Control Solution Level 2 & Level 35100062025-09-26
00015482600501Assure® Titanium Blood Glucose Test Strips6000502025-09-15
00015482601003Assure® Titanium Blood Glucose Test Strips6001002025-09-15
00015482600013Assure® Titanium Blood Glucose Meter6000012025-09-15
10015482600508Assure® Titanium Blood Glucose Test Strips6000502025-09-15
10015482601000Assure® Titanium Blood Glucose Test Strips6001002025-09-15
00015482510046Assure® Control - Control Solution Level 15100042019-04-01
00015482510053Assure® Control - Control Solution Level 25100052019-04-01
00015482510077Assure® Control - Control Solution Level 35100072019-04-01
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482511104GLUCOCARD® W Blood Glucose Monitoring System 5111002019-04-01
00015482512057GLUCOCARD® W Blood Glucose Test Strips5120502019-04-01
10015482102910ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
10015482102958ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
30015482501779Assure® Platinum Blood Glucose Meter5011772022-06-17

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Primary DI, Brand, Company table
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