Model: UA-8010BLEWM
Catalog: UA-8010BLEWM
DI: 00194346614028
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-04
Current Version: 2026-05-12
Description
Upper Arm Blood Pressure Monitor
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4600c42e-73ce-4db3-b38e-4e9af7e4c4b1
Distribution Status:
In Commercial Distribution
DUNS Number:
051957769
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00194346614028
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 16173
Name: Automatic-inflation electronic sphygmomanometer, non-portable
Definition:
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.
FDA Product Codes
DXN
System, Measurement, Blood-Pressure, Non-Invasive