BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Upper Arm Blood Pressure Monitor

DI: 00073796760069 · Model: HEM-7600T-CD6 · Omron Healthcare, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: Upper Arm Blood Pressure Monitor
Primary DI: 00073796760069
Version / Model: HEM-7600T-CD6
Catalog Number: HEM-7600T-CD6
Company Name: Omron Healthcare, Inc.
Labeler DUNS: 054318779
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-07-15
Public Version: 1
Public Version Date: 2025-07-23
Public Version Status: New
Public Device Record Key: b1a5adf7-b2f0-4ac3-8cfd-286ac1dc441b

Device Description

Omron Upper Arm Blood Pressure Monitor with Bluetooth smart connectivity. 100 memory storage for one user. One piece design.

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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16173	Automatic-inflation electronic sphygmomanometer, non-portable	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10073796760066	GS1	case	6	In Commercial Distribution
Primary	00073796760069	GS1

Customer Contacts

Phone: 800-634-4350
Email: [email protected]

Storage Conditions

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