Identity
- Trade Name
- Bigfoot Unity FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Bigfoot Unity Support Kit FDA UDI
- Model / Reference
- FG-300993 FDA UDI
- Description
- Bigfoot Unity Support Kit FDA UDI
Identifiers
- Catalog Number
- FG-300993 FDA UDI
- Primary DI / UDI-DI
- 00850003506593 FDA UDI
- 510(k) Number
- K202145 FDA UDI
- FDA Product Code
- QLG FDA UDIQOG FDA UDIFMK FDA UDINBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1355 FDA UDI880.5860 FDA UDI878.4850 FDA UDI862.1345 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
No
FDA UDI
Convenience Kit
Yes
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: Glucose monitoring system IVD, home-use
Bigfoot Unity by Bigfoot Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202145 also covers:
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
- Bigfoot Unity — BIGFOOT BIOMEDICAL, INC.
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
- Bigfoot Biomedical, Inc.
Sources (1)
- FDA UDI 6f07c50e-cf01-4e48-9a22-bf70ada66316 37 fields · synced Jun 6, 2026