Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
- Device Name
- CONTROL,EVENCARE,G3 HI LO,PROF.USE ONLY FDA UDI
- Model / Reference
- MPH3560 FDA UDI
- Description
- CONTROL,EVENCARE,G3 HI LO,PROF.USE ONLY FDA UDI
Identifiers
- Catalog Number
- MPH3560 FDA UDI
- Primary DI / UDI-DI
- 30884389831216 FDA UDI
- FDA Product Code
- NBW FDA UDIJJX 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 UDI862.1660 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
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: Home-use/point-of-care blood glucose monitoring system IVD
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K113098 also covers:
- GLUCOCARD® EXPRESSION Blood Glucose Monitoring System — ARKRAY USA, INC.
- GLUCOCARD® EXPRESSION Blood Glucose Monitoring System — ARKRAY USA, INC.
- GLUCOCARD® EXPRESSION Blood Glucose Test Strips — ARKRAY USA, INC.
- GLUCOCARD® EXPRESSION Blood Glucose Test Strips — ARKRAY USA, INC.
- GLUCOCARD® EXPRESSION Blood Glucose Test Strips — ARKRAY USA, INC.
- Medline — MEDLINE INDUSTRIES, INC.
K120448 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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 1b8ba456-0eed-4813-9173-e696cf94c8e2 37 fields · synced May 30, 2026