AccessGUDID - DEVICE: Polytel GMA (00861700000314)

GUDID

Device Identifier (DI) Information

Brand Name: Polytel GMA
Version or Model: PWR-08-07
Catalog Number:
Company Name: Polymap Wireless

Primary DI Number: 00861700000314
Issuing Agency: GS1
Device Count: 1

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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.

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: August 02, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: Polytel GMA (00861700000314)