Embrace TALK 100 ct. test strip

GUDID 00894030002727

OMNIS HEALTH, LLC

Glucose monitoring system IVD, home-use
Primary Device ID00894030002727
NIH Device Record Key54d32d95-15bd-4296-82c5-7bd47d9de002
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbrace TALK 100 ct. test strip
Version Model NumberAPX03AB0304
Company DUNS824763358
Company NameOMNIS HEALTH, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100894030002727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-10
Device Publish Date2019-12-02

Devices Manufactured by OMNIS HEALTH, LLC

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