FDA.reportPublic FDA data

On Call Vivid Glucose Control Solution Kit

Primary DI
00682607556311
Brand
On Call Vivid Glucose Control Solution Kit
Company
Acon Laboratories, Inc.
Model
G125-122
Device description
Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2
Published
2016-09-24
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
JJXSingle (specified) analyte controls (assayed and unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112653000ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMSACON Laboratories, Inc.2012-04-09JJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10682607556318PackageGS124In Commercial Distribution
20682607556315PackageGS16In Commercial Distribution
00682607556311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068260755631810682607556318
2068260755631520682607556315
00682607556311006826075563116826075563110682607556311

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
Special Storage Condition, Specify00Keep out of direct sunlight
Special Storage Condition, Specify00Store in a cool, dry place
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)838-9502support@aconlabs.com

Regulatory Flags#

DUNS number
781100966
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1012026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1042026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1052026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1012026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1022026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1042026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1052026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONOGS-211G125-22U-1012026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMOGM-211G115-20U-1012026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-21U-1012026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-22U-1012026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-23U-1012026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMOGM-212G115-20W-1012026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-21W-1012026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-22W-1012026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-23W-1012026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMOGM-511GK115-201-1012026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METEROGM-511GK115-221-1012026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMOGM-512GK115-222-1012026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONOGC-511GK125-221-1012026-07-30

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