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Polytel GMA

FDA UDI

Class II (US FDA UDI)

by Polymap Wireless, LLC

Identity

Trade Name
Polytel GMA FDA UDI
Generic Name
Medical networking interface unit FDA UDI
Device Name
Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Abbott. Specific meters supported are FreeStyle Lite and FreeStyle Freedom Lite FDA UDI
Model / Reference
PWR-08-09 FDA UDI
Description
Glucose meter accessory providing Bluetooth connectivity to glucose meters manufactured by Abbott. Specific meters supported are FreeStyle Lite and FreeStyle Freedom Lite FDA UDI

Identifiers

Primary DI / UDI-DI
00861700000321 FDA UDI
FDA Product Code
NBW FDA UDI
GMDN Term
Medical networking interface unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical networking interface unit

Polytel GMA by Polymap Wireless, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical networking interface unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Polymap Wireless, LLC

Sources (1)

  • FDA UDI 05e6c0da-4fc1-418e-831f-f3711b2c6737 35 fields · synced May 30, 2026