Easy Step Blood Glucose Monitoring System

Primary DI
00891237001188
Brand
Easy Step Blood Glucose Monitoring System
Company
HOME AIDE DIAGNOSTICS, INC.
Model
T5D4-00
Catalog number
1188
Device description
Blood Glucose Testing Monitor to be used with Easy Step test stripsTest Sample:Capillary Whole Blood from Fingertip, Palm and ForearmSample Volume:>0.5 uLMeasuring Unit:mg/dL or mmol/LMeasuring Range:20 - 600 mg/dL (1.1 - 33.3 mmol/L)Test Time:5 secMemory Capacity:300 most recent resultsAverage:7/14/30 days average resultsExternal Output: USB data portPower supply:One 3-Volt lithium battery (CR-2032)Battery Life:Approximately 1000 testsDimension and Weight:79 x 60 x17 mm ; 55 g
Published
2016-05-01
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
K090629000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090629000EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMSTyson Bioresearch, Inc.2009-06-04NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10891237001185PackageGS1112In Commercial Distribution
00891237001188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089123700118510891237001185
00891237001188008912370011888912370011880891237001188

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 Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Special Storage Condition, Specify00Keep meter within 39-86 oF (4-30 oC) and out of direct sunlight

Contacts#

Phone, Email table
PhoneEmail
18009150116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
1
Lot or batch
true
Expiration date on label
true

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