AILE Electronic Sphygmomanometers

GUDID 06972480913054

Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.

Jiangxi Aicare Medical Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06972480913054
• NIH Device Record Key: 3f0000c8-fb4f-4875-a1df-62abe9381e75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AILE Electronic Sphygmomanometers
• Version Model Number: X11
• Company DUNS: 554530454
• Company Name: Jiangxi Aicare Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972480913054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221040

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-13
• Device Publish Date: 2023-03-04

On-Brand Devices [AILE Electronic Sphygmomanometers]

• 06972480916383: Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as
• 06972480913054: Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as
• 06972480913047: Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as
• 06972480913030: Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as
• 06972480913023: Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as
• 06972480913009: Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as
• 06972480912996: Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as