Embrace TALK Blood Glucose Monitor (Pre-Pack)

GUDID 00894030002970

OMNIS HEALTH, LLC

Glucose monitoring system IVD, home-use
Primary Device ID00894030002970
NIH Device Record Key094a5e62-ce88-4e84-9eb5-49728213c3f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbrace TALK Blood Glucose Monitor (Pre-Pack)
Version Model NumberAPX03AB0300PRE
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 Usefalse
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
GS100894030002970 [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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