AccessGUDID - DEVICE: Health Sense Upper Arm Blood Pressure Monitor XL cuff (00891237001744)

GUDID

Device Identifier (DI) Information

Brand Name: Health Sense Upper Arm Blood Pressure Monitor XL cuff
Version or Model: BP-1303
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1744
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00891237001744
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: Arm-type fully automatic digital blood pressure monitor. LCD digital display. Oscillometric measurement method. 0mmHg~300mmHg pressure range. 30-180 Beats/Minute. 3mmHg pressure accuracy. 5% pulse accuracy. Automatic Pressurization. 120 Memories in Four groups with date and time. low battery detection. Automatic Power-off. 4 AA batteries. Approximately 2 months at 3 test per day battery life. 22.0cm ~36.0cm (8.6" ~14.2") cuff cirfumference.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51432422-8d4b-4d4f-854f-0d78c3b5c449
Public Version Date: November 08, 2019
Public Version Number: 4
DI Record Publish Date: May 01, 2016