EasyWear Cuff

GUDID 00812345023350

Blood Pressure Cuff

MORTARA INSTRUMENT, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00812345023350
• NIH Device Record Key: 5dc6f30f-1da7-46dd-8071-0aacd739bf0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyWear Cuff
• Version Model Number: 008-0005-01
• Company DUNS: 062046149
• Company Name: MORTARA INSTRUMENT, INC.
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com
• Phone: 888-667-8272
• Email: techsupport@mortara.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812345023350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080274
• Premarket Notification: K133989

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-06-29
• Device Publish Date: 2016-09-24

Devices Manufactured by MORTARA INSTRUMENT, INC.

• 21081234502471 - Quik-Prep: 2020-07-20 Electrodes
• 10812345022176 - Clear Choice Adapter: 2020-06-29 ECG Adapter
• 10812345023050 - Snap Adapter: 2020-06-29 ECG Adapter
• 20812345024238 - Quick-Trace Multi-purpose ECG electrodes: 2020-06-29 Electrodes
• 30812345024686 - CardioSens/Ultra II: 2020-06-29 Electrodes
• 30812345024723 - Resting Tab Type Electrodes: 2020-06-29 Electrodes
• 20812345024733 - ECG Monitoring Electrodes: 2020-06-29 Electrodes
• 21081234502474 - Quik-Prep: 2020-06-29 Electrodes