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 LifeScan Inc. Specific meters supported are OneTouch Ultra, OneTouch Ultra2, OneTouch UltraMini, OneTouch UltraEasy FDA UDI
- Model / Reference
- PWR-08-06 FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861700000307 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
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Polymap Wireless, LLC
Sources (1)
- FDA UDI 984d8581-1bce-4df5-89a1-82ba074425d3 34 fields · synced May 30, 2026