ENTRA HEALTH SYSTEMS LLC

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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) (1) Glucose Oxidase, Glucose (CGA) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) System, Test, Blood Glucose, Over The Counter (NBW) (1)

Premarket Exempt

No Yes

Clear

MyGlucoHealth® BT Meter - 00852668007095 Catalog Number :

Device Description : Blood Glucose meter (label)

Device Class : 2

Duns Number: 826314044

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

BLE Smart® Control Solution - 00852668007187 Catalog Number :

Device Description : Control Solution Box 3 Pack

Device Class : 1

Duns Number: 826314044

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

MyGlucoHealth Test Strips - 10850081003011 Catalog Number :

Device Description : Glucose Test Strip Vial Label

Device Class : 2

Duns Number: 826314044

Premarket Exempt : No

Product Code : CGA

Prescription Use : Yes

Device Count : 1

BLE Smart Test Strip - 10852668007016 Catalog Number :

Device Description : BLE Smart Test Strip Vial

Device Class : 2

Duns Number: 826314044

Premarket Exempt : No

Product Code : LFR

Prescription Use : Yes

Device Count : 1

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