OMNIS HEALTH

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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) (6) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (6) System, Test, Blood Glucose, Over The Counter (NBW) (2)

Premarket Exempt

Clear

Embrace Meter, Meter Only - 00894030002017 Catalog Number :

Device Class : 1

Duns Number: 023891520

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : No

Device Count : 1

Embrace Strips, 50ct Vial - Distributor partner - 00894030002024 Catalog Number :

Device Class : 2

Duns Number: 023891520

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Embrace Control Solution, L2 (High) - 00894030002062 Catalog Number :

Device Class : 1

Duns Number: 023891520

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Embrace Control Solution, L1 (Low) - 00894030002079 Catalog Number :

Device Class : 1

Duns Number: 023891520

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Embrace Strips, 10-ct - 00894030002086 Catalog Number :

Device Class : 2

Duns Number: 023891520

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Embrace Meter Kit (w/10 ct) - 00894030002260 Catalog Number :

Device Class : 1

Duns Number: 023891520

Premarket Exempt : No

Product Code : LFR, JJX, NBW

Prescription Use : No

Device Count : 1

Embrace Strips, 50ct Vial - Mail Order (Yellow Band) - 00894030002338 Catalog Number :

Device Class : 2

Duns Number: 023891520

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Embrace EVO Control Solution, L1 (Low) - 00894030002345 Catalog Number :

Device Class : 1

Duns Number: 023891520

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Embrace EVO Strips, 50ct Vial - RETAIL - 00894030002352 Catalog Number :

Device Class : 2

Duns Number: 023891520

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

Embrace EVO Control Solution, L2 (Medium) - 00894030002376 Catalog Number :

Device Class : 1

Duns Number: 023891520

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

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