Polymap Wireless

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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

Medical Device Data System (OUG) (5) System, Test, Blood Glucose, Over The Counter (NBW) (3)

Premarket Exempt

No Yes

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Polytel GMA - 00861700000307 Catalog Number :

Device Description : Glucose meter accessory providing Bluetooth connectivity to glucose meters manuf Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by LifeScan Inc. Specific meters supported are OneTouch Ultra, OneTouch Ultra2, OneTouch UltraMini, OneTouch UltraEasy

Device Class : 2

Duns Number: 108359188

Premarket Exempt : No

Product Code : NBW

Prescription Use : Yes

Device Count : 1

Polytel GMA - 00861700000314 Catalog Number :

Device Description : Glucose meter accessory providing Bluetooth connectivity to glucose meters manuf Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Bayer. Specific meters supported are Breeze2, Contour, Contour TS, Contour next EZ.

Device Class : 2

Duns Number: 108359188

Premarket Exempt : No

Product Code : NBW

Prescription Use : Yes

Device Count : 1

Polytel GMA - 00861700000321 Catalog Number :

Device Description : Glucose meter accessory providing Bluetooth connectivity to glucose meters manuf Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Abbott. Specific meters supported are FreeStyle Lite and FreeStyle Freedom Lite

Device Class : 2

Duns Number: 108359188

Premarket Exempt : No

Product Code : NBW

Prescription Use : Yes

Device Count : 1

Polytel GMA2 - 00861700000338 Catalog Number :

Device Description : Glucose meter accessory providing Bluetooth connectivity for existing glucose me Glucose meter accessory providing Bluetooth connectivity for existing glucose meters. Depending on which cable is provisioned, this device supports different existing glucose meters."L" cable: LifeScan OneTouch Ultra, Ultra2, UltraMini, UltraEasy, Select, Basic"B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ, "A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite

Device Class : 1

Duns Number: 108359188

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Polytel - 00861700000345 Catalog Number : RPLYX01

Device Description : This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters This cable is used to connect the Polytel PWR-09-02 GMA2 unit to glucose meters from LifeScan

Device Class : 1

Duns Number: 108359188

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Polytel - 00861700000352 Catalog Number : RPLYX02

Device Description : Cable to be used with Polytel PWR-09-02 GMA2 to support Abbott glucose meters

Device Class : 1

Duns Number: 108359188

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Polytel - 00861700000369 Catalog Number : RYPLX03

Device Description : Cable to connect Polytel PWR-09-02 GMA2 to Bayer family glucose meters

Device Class : 1

Duns Number: 108359188

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Polytel - 00861700000376 Catalog Number :

Device Description : Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bl Glucose Meter Accessory for existing glucose meters from LifeScan, providing Bluetooth 2.1 connectivity for telehealth applications. This is built on a PWR-09-02 device, which an also support other glucose meter families if appropriate cables are provided:"B" cable: Bayer Breeze2, Contour, Contour TS, Contour XT, Contour next EZ,"A" cable: Abbott FreeStyle Lite, FreeStyle Freedom Lite

Device Class : 1

Duns Number: 108359188

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

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