ENTRA HEALTH SYSTEMS LLC

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

System, Test, Blood Glucose, Over The Counter (NBW) (5) Glucose Oxidase, Glucose (CGA) (2) Glucose Dehydrogenase, Glucose (LFR) (1) Lancet, Blood (FMK) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

MyGlucoHealth® BT Meter Kit - 00850081003007 Catalog Number :

Device Description : Blood Glucose Meter Kit

Device Class : 2

Duns Number: 826314044

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

MyGlucoHealth® Test Strips - 00850081003014 Catalog Number :

Device Description : Blood Glucose Test Strips

Device Class :

Duns Number: 826314044

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 50

MyGlucoHealth Lancets - 00850081003038 Catalog Number :

Device Description : Lancets

Device Class : 2

Duns Number: 826314044

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

MyGlucoHealth® Control Solution 3-Pack - 00850081003212 Catalog Number :

Device Description : Control Solution 3 Pak

Device Class : 1

Duns Number: 826314044

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

BLE Smart® Test Strips - 00850081003960 Catalog Number :

Device Description : Glucose Test Strips

Device Class : 2

Duns Number: 826314044

Premarket Exempt : No

Product Code : LFR

Prescription Use : No

Device Count : 1

BLE Smart® Test Strips - 00852668007019 Catalog Number :

Device Description : Glucose Test Strips Unit of Use (each individual test strip)

Device Class : 2

Duns Number: 826314044

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 1

MyGlucoHealth® Wireless Blood Glucose System - 00852668007040 Catalog Number :

Device Description : Wireless Blood Glucose Meter Kit

Device Class : 2

Duns Number: 826314044

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

MyGlucoHealth® Wireless Blood Glucose Meter - 00852668007057 Catalog Number :

Device Description : Wireless Blood Glucose Meter

Device Class : 2

Duns Number: 826314044

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

BLE Smart® Blood Glucose System - 00852668007064 Catalog Number :

Device Description : Blood Glucose Meter Kit

Device Class : 2

Duns Number: 826314044

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

BLE Smart® Blood Glucose Meter - 00852668007071 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

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