OMNIS HEALTH, LLC

Address:1736 River Hills Drive Suite 6,Nashville,TN,37210,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Glucose Dehydrogenase, Glucose (LFR) (5) System, Test, Blood Glucose, Over The Counter (NBW) (4) Lancet, Blood (FMK) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (3) Multiple Use Blood Lancet For Single Patient Use Only (QRL) (1) Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (QRK) (1)

Premarket Exempt

No Yes

Clear

Embrace TALK Blood Glucose Monitor - 00894030002000 Catalog Number :

Device Description : Meter Only

Device Class : 1

Duns Number: 824763358

Premarket Exempt : No

Product Code : NBW, JJX, LFR

Prescription Use : No

Device Count : 1

Embrace Lancet - 00894030002048 Catalog Number :

Device Description : Embrace Lancet 30G

Device Class : 2

Duns Number: 824763358

Premarket Exempt : No

Product Code : QRK, QRL

Prescription Use : No

Device Count : 1

Embrace Safety Lancet - 00894030002512 Catalog Number :

Device Description : Embrace Safety Lancet 21G/2.2mm 100ct.

Device Class : 2

Duns Number: 824763358

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Embrace Blood Glucose Monitor - 00894030002611 Catalog Number :

Device Class : 1

Duns Number: 824763358

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : No

Device Count : 1

Embrace Safety Lancet - 00894030002659 Catalog Number :

Device Description : Embrace Safety Lancet 30G/1.8mm 100ct.

Device Class : 2

Duns Number: 824763358

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Embrace Safety Lancet - 00894030002673 Catalog Number :

Device Description : Embrace Safety Lancet 23G/1.8mm 100ct.

Device Class : 2

Duns Number: 824763358

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Embrace TALK 50 ct. test strip - 00894030002710 Catalog Number :

Device Class : 2

Duns Number: 824763358

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Embrace TALK 100 ct. test strip - 00894030002727 Catalog Number :

Device Class : 2

Duns Number: 824763358

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

HealthWise Embrace TALK Blood Glucose Monitoring System (Meter Only) - 00894030002819 Catalog Number :

Device Class : 2

Duns Number: 824763358

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

HealthWise Embrace TALK Blood Glucose Monitoring System (Starter Kit) - 00894030002826 Catalog Number :

Device Class : 1

Duns Number: 824763358

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : No

Device Count : 1

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