Easy Talk/PlusII Control Solution LOW

GUDID 10850027494309

Easy Talk/PlusII Control Solution LOW

HOME AIDE DIAGNOSTICS, INC.

Glucose IVD, control
Primary Device ID10850027494309
NIH Device Record Keyf6a9b4ec-79ff-43cf-b7de-20fa74325e52
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy Talk/PlusII Control Solution LOW
Version Model NumberET-PIICTR
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100850027494302 [Primary]
GS110850027494309 [Package]
Contains: 00850027494302
Package: Case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove

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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