simpleABI ABI-500CL

GUDID 00852785008616

ABI-500CL Software, 8 port Cuff-Link w remote, 8MHz Doppler probe, PPG, 2x10cm cuffs, 4x12cm cuffs, 2x12cm long cuffs, 2x2.5cm disposable digit cuffs, roll stand, user manual, quick reference guides.

NEWMAN MEDICAL LLC

Noninvasive vascular ultrasound system, battery-powered Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system Noninvasive vascular ultrasound system

• Primary Device ID: 00852785008616
• NIH Device Record Key: 36932882-91dd-41a8-b74e-bc6d31968e5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: simpleABI
• Version Model Number: ABI-500CL
• Catalog Number: ABI-500CL
• Company DUNS: 078686903
• Company Name: NEWMAN MEDICAL LLC
• 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: false
• Serial Number: true
• 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: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852785008616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110628

FDA Product Code

• JAF: Monitor, Ultrasonic, Nonfetal

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: 2018-07-09
• Device Publish Date: 2018-06-08

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• 00852785008623: ABI-450CL Software, 4 port Cuff-Link with remote, 8MHz Doppler probe, PPG, 2x10cm cuffs, 2x12cm
• 00852785008616: ABI-500CL Software, 8 port Cuff-Link w remote, 8MHz Doppler probe, PPG, 2x10cm cuffs, 4x12cm cuf
• 00852785008609: ABI-600CL Software, 8 port Cuff-Link w remote, 8MHz Doppler probe, PPG, 2x10cm cuffs, 4x12cm cuf
• 00852785008661: ABI-Q Software, PVR, 2x10cm cuffs, inflation bulb, carry bag, user manual, quick reference guid