Identity
- Trade Name
- Prodigy Value Pack FDA UDI
- Generic Name
- Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
- Device Name
- Prodigy Value Pack 12 x Item # 073200; 4 x Item # 07120 FDA UDI
- Model / Reference
- 075150 FDA UDI
- Description
- Prodigy Value Pack 12 x Item # 073200; 4 x Item # 07120 FDA UDI
Identifiers
- Catalog Number
- 075150 FDA UDI
- Primary DI / UDI-DI
- 00384840751507 FDA UDI
- FDA Product Code
- CGA FDA UDINBW FDA UDI
- GMDN Term
- Home-use/point-of-care blood glucose monitoring system IVD 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, kit, electrometryManual blood lancing device, reusableHome-use/point-of-care blood glucose monitoring system IVD
Prodigy Value Pack by Prodigy Diabetes Care, 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
- Prodigy Diabetes Care, Llc
Sources (1)
- FDA UDI 9a9f6c83-f306-4f91-87ae-937afcb73082 35 fields · synced Jun 8, 2026