Easy Step Blood Glucose Monitoring System

FDA UDI

Class II (US FDA UDI)

by Home Aide Diagnostics, Inc.

Identity

Trade Name: Easy Step Blood Glucose Monitoring System FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: Blood Glucose Testing Monitor to be used with Easy Step test strips Test Sample:Capillary Whole Blood from Fingertip, Palm and Forearm Sample Volume:>0.5 uL Measuring Unit:mg/dL or mmol/L Measuring Range:20 - 600 mg/dL (1.1 - 33.3 mmol/L) Test Time:5 sec Memory Capacity:300 most recent results Average:7/14/30 days average results External Output: USB data port Power supply:One 3-Volt lithium battery (CR-2032) Battery Life:Approximately 1000 tests Dimension and Weight:79 x 60 x17 mm ; 55 g FDA UDI
Model / Reference: T5D4-00 FDA UDI
Description: Blood Glucose Testing Monitor to be used with Easy Step test strips Test Sample:Capillary Whole Blood from Fingertip, Palm and Forearm Sample Volume:>0.5 uL Measuring Unit:mg/dL or mmol/L Measuring Range:20 - 600 mg/dL (1.1 - 33.3 mmol/L) Test Time:5 sec Memory Capacity:300 most recent results Average:7/14/30 days average results External Output: USB data port Power supply:One 3-Volt lithium battery (CR-2032) Battery Life:Approximately 1000 tests Dimension and Weight:79 x 60 x17 mm ; 55 g FDA UDI

Identifiers

Catalog Number: 1188 FDA UDI
Primary DI / UDI-DI: 00891237001188 FDA UDI
510(k) Number: K090629 FDA UDI
FDA Product Code: NBW FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose monitoring system IVD, home-use

Easy Step Blood Glucose Monitoring System by Home Aide Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose monitoring system IVD, home-use.

Gmate® Origin Blood Glucose Monitoring System — Philosys, Inc. · Class II
One Drop — INFORMED DATA SYSTEMS INC. · Class II
TRUE METRIX GO — TRIVIDIA HEALTH, INC. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC. · Class II
LEADER — Cardinal Health 110, Inc. · Class II
CareSens N Voice Multi — i-SENS, Inc. · Class II

Cleared under the same submission

K090629 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Home Aide Diagnostics, Inc.

Sources (1)

FDA UDI ad3fa71e-6906-42f6-8d2b-2c4cdd0f03ff 37 fields · synced May 30, 2026