ARCADIA GROUP

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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) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (4)

Premarket Exempt

Clear

Choice - 00860418002603 Catalog Number :

Device Description : Blood Glucose Monitoring System, Choice Basic

Device Class : 2

Duns Number: 555630941

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Choice - 00860418002610 Catalog Number :

Device Description : Blood Glucose Monitoring System, Choice

Device Class : 2

Duns Number: 555630941

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Choice Basic Blood Pressure Monitor - 00860418002658 Catalog Number :

Device Description : Digital Blood Pressure Monitor.

Device Class : 2

Duns Number: 555630941

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Choice Basic Blood Pressure Monitor, Multi-User - 00860418002665 Catalog Number : UA-767F-CP

Device Description : Digital Blood Pressure Monitor.

Device Class : 2

Duns Number: 555630941

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Choice Basic Wrist Blood Pressure Monitor - 00860418002672 Catalog Number : UB-543-CP

Device Description : Digital Wrist Blood Pressure Monitor.

Device Class : 2

Duns Number: 555630941

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Choice Wireless Upper Arm Blood Pressure Monitor - 00860418002689 Catalog Number : UA-651BLE-CP

Device Description : Digital Blood Pressure Monitor

Device Class : 2

Duns Number: 555630941

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Choice - 10860418002600 Catalog Number :

Device Description : Blood Glucose Meter, Choice Basic

Device Class : 2

Duns Number: 555630941

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Choice - 10860418002617 Catalog Number :

Device Description : Blood Glucose Meter, Choice

Device Class : 2

Duns Number: 555630941

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Choice - 10860418002624 Catalog Number :

Device Description : Test Strips, Choice, 50CT, 100CT, 200CT

Device Class :

Duns Number: 555630941

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 50

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