Easy Talk/Plus II Glucose Test Strips

GUDID 10850027494224

Box of 50 Glucose Strips compatible with Easy Talk Glucose Monitor and Easy Plus II Glucose Monitor

HOME AIDE DIAGNOSTICS, INC.

Glucose monitoring system IVD, home-use
Primary Device ID10850027494224
NIH Device Record Key7557e70f-7513-4ea4-af95-9228c5a2e1e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy Talk/Plus II Glucose Test Strips
Version Model NumberET-PIISTR
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us
Phone8009150116
Emailinfo@homeaide.us

Device Identifiers

Device Issuing AgencyDevice ID
GS100850027494227 [Primary]
GS110850027494224 [Package]
Contains: 00850027494227
Package: Box [2 Units]
In Commercial Distribution
GS120850027494221 [Package]
Package: Inner Carton [20 Units]
In Commercial Distribution
GS130850027494228 [Package]
Contains: 20850027494221
Package: Case [20 Units]
In Commercial Distribution
GS140850027494225 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-24
Device Publish Date2024-06-14

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