Identity
- Trade Name
- FreeStyle Precision Neo FDA UDI
- Generic Name
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
- Device Name
- FreeStyle Precision Neo Blood Glucose Test Strips FDA UDI
- Model / Reference
- 71577 FDA UDI
- Description
- FreeStyle Precision Neo Blood Glucose Test Strips FDA UDI
Identifiers
- Catalog Number
- 71577 FDA UDI
- Primary DI / UDI-DI
- 00093815715771 FDA UDI
- FDA Product Code
- NBW FDA UDILFR FDA UDI
- GMDN Term
- Multiple clinical chemistry analyte monitoring system IVD, home-use 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple clinical chemistry analyte monitoring system IVD, home-use
FreeStyle Precision Neo by Abbott Diabetes Care Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142928 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
Sources (1)
- FDA UDI dddb0b0d-4564-4a55-adc9-35a0779ac557 37 fields · synced May 30, 2026