FDA.reportPublic FDA data

On Call Express Blood Glucose Monitoring System

Primary DI
00024291121831
Brand
On Call Express Blood Glucose Monitoring System
Company
NAVAJO MANUFACTURING COMPANY
Model
G115-10D
Device description
Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Published
2020-03-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
JJXSingle (specified) analyte controls (assayed and unassayed)
NBWSystem, test, blood glucose, over the counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10024291121838PackageGS13Not in Commercial Distribution
20024291121835PackageGS18Not in Commercial Distribution
00024291121831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002429112183810024291121838
2002429112183520024291121835
00024291121831000242911218310242911218310024291121831

GMDN Terms#

Term, Definition table
TermDefinition
Blood glucose/blood pressure monitoring system, home-useA collection of devices intended for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure; 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. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Contacts#

Phone, Email table
PhoneEmail
+1(303)292-3090fmorales@navajoinc.com

Regulatory Flags#

DUNS number
136941411
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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