Identity
- Trade Name
- Eocene FDA UDI
- Generic Name
- Blood glucose/blood pressure monitoring system, home-use FDA UDI
- Device Name
- Smart Diabetes Bluetooth Glucose Monitor FDA UDI
- Model / Reference
- EHS-SDMK-BT FDA UDI
- Description
- Smart Diabetes Bluetooth Glucose Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854067005191 FDA UDI
- 510(k) Number
- K111456 FDA UDI
- FDA Product Code
- JJX FDA UDICGA FDA UDINBW FDA UDI
- GMDN Term
- Blood glucose/blood pressure monitoring system, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood glucose/blood pressure monitoring system, home-useGlucose rapid test/blood pressure system analyser, point-of-care
Eocene by Value Providers Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose rapid test/blood pressure system analyser, point-of-care.
- Eocene — VALUE PROVIDERS LLC · Class II
- Smart Diabetes — VALUE PROVIDERS LLC · Class II
Cleared under the same submission
K111456 also covers:
- CareLiving MM1100 Blood Glucose Meter — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Blood Glucose Monitoring System — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Blood Glucose Test Strips 100ct — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Blood Glucose Test Strips 50ct — CARE LIVING DIAGNOSTICS INC
- CareLiving MM1100 Control Solution For Blood Glucose — CARE LIVING DIAGNOSTICS INC
- Care Touch — FUTURE DIAGNOSTICS LLC
- Care Touch — FUTURE DIAGNOSTICS LLC
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- TECO DIAGNOSTICS — TECO DIAGNOSTICS
- Teco Diagnostics Glucopad Blood Glucose Test Strips — TECO DIAGNOSTICS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Value Providers Llc
Sources (1)
- FDA UDI 05f5d4fd-6a7f-451f-97d9-f37cdfdcc7fa 35 fields · synced Jun 8, 2026