FDA.report

Easy Talk Blood Glucose Monitoring System

Primary DI
00891237001478
Brand
Easy Talk Blood Glucose Monitoring System
Company
HOME AIDE DIAGNOSTICS, INC.
Model
6277
Catalog number
1478
Device description
Blood Glucose Testing Monitor to be used with Easy Talk or Easy Plus II test strips Test: Glucose Sample: Whole Blood Principle of the test method: Amperometric, glucose oxidase Test sites: Fingertip, forearm Measurement time: 6 seconds Code required: No code device Measurement Range: 20~600 mg/dL (1.1~33.3mmol/L ). Batteries: 2 x AAA 1.5 V Alkaline 24A LR03
Published
2016-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10891237001475PackageGS15In Commercial Distribution
20891237001472PackageGS110In Commercial Distribution
00891237001478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1089123700147510891237001475
2089123700147220891237001472
00891237001478008912370014788912370014780891237001478

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
18009150116info@homeaide.us

Regulatory Flags

DUNS number
783518983
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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