FDA.reportPublic FDA data

Easy Trak II Control Solution High

Primary DI
00850632007386
Brand
Easy Trak II Control Solution High
Company
HOME AIDE DIAGNOSTICS, INC.
Model
1
Device description
Easy Trak II Control Solution High for use with Easy Trak II strips in the Easy Trak II meter. For use only within 90 days of opening.Do not use after expiration date.
Published
2020-01-10
Public version status
New
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
K052208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052208000GLUCOSE PILOTTianjin New Bay Bioresearch Co., Ltd.2005-12-09NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850632007383PackageGS1750In Commercial Distribution
00850632007386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085063200738310850632007383
00850632007386008506320073868506320073860850632007386

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
Storage Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-915-0116info@homeaide.us

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00891237001195Easy Step Blood Glucose Test Strips 50ctT5D2-0011952016-05-03
00891237001423Easy Trak Blood Glucose Test Strips 25ct20002004914232016-05-03
00891237001485Easy Talk Blood Glucose Testing Strips 25ct881814852016-05-03
00891237001645Easy Plus II Blood Glucose Testing Strips 25ct881816452016-05-03
00850027494654"Easy Comfort Syringes 31G 5/16"" 0.3CC"46542024-10-08
00850027494661"Easy Comfort Syringes 31G 1/2"" 0.3CC"46612024-10-08
00850027494975Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count49752024-10-08
00850027494982Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count49822024-10-08
00850027494999Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count49992024-10-08
00891237001034Comfort Heal Heating PadJY610110342018-02-14
00850027494517Smart Neb Pediatric NebulizerSNebPN2023-11-03
00850632007225Easy NebMCN-S600MB72252018-01-26
00850632007553Pure Air Mini NebulizerMCN-S600A2020-03-24
00891237001607Easy Air Compressor NebulizerMCN-S600MC16072016-05-01
00850058864082Easy Comfort 3L Sharps Container {3.17 Quarts}SC3L2024-06-14
00850027494340True Comfort Knee Compression Wrap43402024-10-08
00850027494357Pure Comfort Leg Massager43572024-10-08
00850027494388Ultra Comfort Body Massager43882024-10-08

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Primary DI, Brand, Company table
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30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
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10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
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00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
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10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
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