Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Blood glucose/blood pressure monitoring system, home-use FDA UDI
- Device Name
- CONTROL, HARMONY HI LO FDA UDI
- Model / Reference
- MPH6560 FDA UDI
- Description
- CONTROL, HARMONY HI LO FDA UDI
Identifiers
- Catalog Number
- MPH6560 FDA UDI
- Primary DI / UDI-DI
- 10888277675698 FDA UDI
- 510(k) Number
- K161299 FDA UDI
- FDA Product Code
- JJX 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 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: Blood glucose/blood pressure monitoring system, home-use
Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood glucose/blood pressure monitoring system, home-use.
- Health Wealth Safe — Mio Labs Inc. · Class II
- owell — OWELL · Class II
- Eocene — VALUE PROVIDERS LLC · Class I
- owell — OWELL · Class II
- Greater Goods — Greater Goods, LLC · Class II
- Health Wealth Safe — Mio Labs Inc. · Class II
- TeleRPM & Chronica — Mio Labs Inc.
- CURO L5 — KPI HEALTHCARE, INC. · Class II
Cleared under the same submission
K161299 also covers:
- microdot® Pro Control Solution — Cambridge Sensors USA, LLC.
- microdot® Pro Glucometer — Cambridge Sensors USA, LLC.
- microdot® Pro Test Strips (25ct) — Cambridge Sensors USA, LLC.
- microdot® Pro Test Strips (50ct) — Cambridge Sensors USA, LLC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 26d388f9-01fe-4ed3-8dca-9a56a79cbad8 37 fields · synced May 30, 2026