Microlife

Basic Information

• Brand Name: Microlife
• Primary DI: 04719003315085
• Version / Model: CRO-BP3MX1-3C1
• Company Name: MICROLIFE USA, INC.
• Labeler DUNS: 176387785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-11
• Public Version: 1
• Public Version Date: 2025-03-19
• Public Version Status: New
• Public Device Record Key: 21a94dda-8265-4698-a149-b20806712cbd

Device Description

WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64511	Arrythmia-detection sphygmomanometer	An electrically-powered device designed to noninvasively measure blood pressure and, in addition, detect cardiac arrythmias [e.g., atrial fibrillation (AF)] by automatically inflating and deflating a cuff that typically fits around a limb (arm or thigh); it may also measure the heart rate and mean arterial pressure. It typically incorporates a display and controls, and may include a blood pressure cuff with connection tubing. The measurements may be analysed at a medical facility, typically using a computer or mobile phone with a dedicated software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719003315085	GS1
Package	14719003315082	GS1	Gift box	1	In Commercial Distribution
Package	24719003315089	GS1	Inner box	4	In Commercial Distribution
Package	34719003315086	GS1	Carton	8	In Commercial Distribution