DEVICE: Polytel GMA (00861700000314)

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Device Identifier (DI) Information

Polytel GMA
PWR-08-07

Polymap Wireless
00861700000314
GS1
1
Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Bayer. Specific meters supported are Breeze2, Contour, Contour TS, Contour next EZ.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Medical networking interface unit A bench-top electronic unit or device assembly intended to be used during a medical procedure/patient monitoring to interface multiple devices for communication of data (typically from a patient data gathering point to a computer/network server); it is not intended to store data, and is not intended to display data/images. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.
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FDA Product Code

[?]
Product Code Product Code Name
NBW System, Test, Blood Glucose, Over The Counter
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 02, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1 520 747 1811
info@polymap.net
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