Model: UA-1020CEL-CS
Catalog: UA-1020CEL-CS
DI: 00093764604720
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-08
Current Version: 2026-05-18
Description
Digital Blood Pressure Monitor
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
515cfb9e-4ff3-4983-8f13-f0057ddced46
Distribution Status:
In Commercial Distribution
DUNS Number:
691722987
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:
00093764604720
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
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling Low - @attributes - Value:
10
Item #1 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Value:
95
Item #1 - Storage Handling Type:
Storage Environment Humidity
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
-20
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
60
Item #2 - Storage Handling Type:
Storage Environment Temperature
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
-20
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
60
Item #3 - Storage Handling Type:
Handling Environment Temperature
Item #4 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling Low - @attributes - Value:
10
Item #4 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling High - @attributes - Value:
95
Item #4 - Storage Handling Type:
Handling Environment Humidity