Gold Upper Arm Blood Pressure Monitor

Basic Information

• Brand Name: Gold Upper Arm Blood Pressure Monitor
• Primary DI: 00073796253608
• Version / Model: BP5360
• Catalog Number: BP5360
• Company Name: Omron Healthcare, Inc.
• Labeler DUNS: 054318779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-25
• Public Version: 2
• Public Version Date: 2025-06-12
• Public Version Status: Update
• Public Device Record Key: 53d4ca0c-e398-4001-88e0-73036ee513b0

Device Description

Gold Upper Arm Blood Pressure Monitor with Wide-Range D-Ring Cuff, 80 memory readings with blue tooth connectivity, 2 user modes, and possible and Atrial Fibrillation Detection.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
QXY	Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification	Cardiovascular	870.1135	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45617	Automatic-inflation electronic sphygmomanometer, portable, arm/wrist	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10073796253605	GS1	case	10	In Commercial Distribution
Primary	00073796253608	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN230076	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity