Nuubo System 2022

GUDID 08437011759030

Nuubo30 SIII Box USA. Textile with an integrated electrodes technology for sensing the patient’s ECG.

SMART SOLUTIONS TECHNOLOGIES SL

Electrocardiographic lead set, single-use

• Primary Device ID: 08437011759030
• NIH Device Record Key: 4185f04a-1761-461f-80a2-55a3b392bd83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nuubo System
• Version Model Number: 2022
• Catalog Number: 2022
• Company DUNS: 475359621
• Company Name: SMART SOLUTIONS TECHNOLOGIES SL
• Device Count: 1
• DM Exempt: true
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: true

Customer Support Contacts

• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com
• Phone: +34678078697
• Email: pserna@nuubo.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437011759030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173461

FDA Product Code

• DSH: RECORDER, MAGNETIC TAPE, MEDICAL

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: 2019-11-25
• Device Publish Date: 2019-11-15

On-Brand Devices [Nuubo System]

• 08437011759030: Nuubo30 SIII Box USA. Textile with an integrated electrodes technology for sensing the patientâ
• 08437011759023: Nuubo30 SII Box USA. Textile with an integrated electrodes technology for sensing the patientâ€
• 08437011759016: Nuubo30 SI Box USA. Textile with an integrated electrodes technology for sensing the patient’
• 08437011759078: NuuboREC Box USA. Ambulatory ECG monitoring device (Holter) up to 30 days.